Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00205777
Collaborator
(none)
7,609
376
2
105
20.2
0.2
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
7609 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Fracture Incidence Reduction And Safety Of TSE-424 (Bazedoxifene Acetate) Compared To Placebo And Raloxifene In Osteoporotic Postmenopausal Women
Study Start Date
:
Dec 1, 2001
Actual Primary Completion Date
:
Sep 1, 2010
Actual Study Completion Date
:
Sep 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: A
|
Drug: Bazedoxifene Acetate
BZA 20mg, daily, oral
|
| Placebo Comparator: B
|
Other: Placebo
Placebo, daily, oral
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With New Vertebral Fractures Through Month 36 [Baseline through Month 36]
New vertebral fracture: decrease in anterior, mid, or posterior vertebral (vt) height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.
- Percentage of Participants With New Vertebral Fractures Through Month 60 [Baseline through Month 60]
New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.
- Percentage of Participants With New Vertebral Fractures Through Month 84 [Baseline through Month 84]
New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.
Secondary Outcome Measures
- Incidence of Breast Cancer Through Month 36 [Baseline through Month 36]
Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time).
- Incidence of Breast Cancer Through Month 60 [Baseline through Month 60]
Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time).
- Incidence of Breast Cancer Through Month 84 [Baseline through Month 84]
Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time).
- Percentage of Participants With New Clinical Vertebral Fractures Through Month 36 [Baseline through Month 36]
A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base.
- Percentage of Participants With New Clinical Vertebral Fractures Through Month 60 [Baseline through Month 60]
A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base.
- Percentage of Participants With New Clinical Vertebral Fractures Through Month 84 [Baseline through Month 84]
A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base.
- Number of Participants With Worsening Vertebral Fractures Through Month 36 [Baseline through Month 36]
A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline.
- Number of Participants With Worsening Vertebral Fractures Through Month 60 [Baseline through Month 60]
A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline.
- Number of Participants With Worsening Vertebral Fractures Through Month 84 [Baseline through Month 84]
A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline.
- Percentage of Participants With Non-vertebral Fractures Through Month 36 [Baseline through Month 36]
Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.
- Percentage of Participants With Non-vertebral Fractures Through Month 60 [Baseline through Month 60]
Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.
- Percentage of Participants With Non-vertebral Fractures Through Month 84 [Baseline through Month 84]
Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.
- Change From Baseline in Height at Month 36 [Baseline, Month 36]
Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).
- Change From Baseline in Height at Month 60 [Baseline, Month 60]
Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).
- Change From Baseline in Height at Month 84 [Baseline, Month 84]
Height (cm) was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).
- Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 [Baseline, Months 6, 12, 18, 24, 36]
BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher.
- Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 [Baseline, Month 48, 60]
BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher.
- Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84 [Baseline, Month 72, 84]
BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher.
- Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12 [Baseline, Months 3, 6, 12]
Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.
- Percent Change From Baseline in Osteocalcin at Months 36 and 60 [Baseline, Months 36, 60]
Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.
- Percent Change From Baseline in Osteocalcin at Months 72 and 84 [Baseline, Months 72, 84]
Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.
- Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12 [Baseline, Months 3, 6, 12]
C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.
- Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60 [Baseline, Months 36, 60]
C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.
- Percent Change From Baseline in C-telopeptide (CTx) at Months 72 and 84 [Baseline, Months 72, 84]
C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.
- Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 [Baseline, Months 6, 12, 24, 36]
Lipid parameters evaluated included total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL), triglyceride (TG), high-density lipoprotein fraction 2 (HDL2) and high-density lipoprotein fraction 3 (HDL3).
- Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP [Month 36]
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Percentage of following indices (volume,surface,porosity) was calculated:Bone Volume(BV), Osteoid Volume(OV), Osteoid Surface(OS), Osteoclast Surface(OcS), Osteoblast Surface(ObS), Mineralizing surface(MS), Eroded Surface(ES), Osteoid Mineralizing surface(OMS), Cortical porosity(CP).
- Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP [Month 60]
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Percentage of following indices (volume,surface,porosity) was calculated:Bone Volume(BV), Osteoid Volume(OV), Osteoid Surface(OS), Osteoclast Surface(OcS), Osteoblast Surface(ObS), Mineralizing surface(MS), Eroded Surface(ES), Osteoid Mineralizing surface(OMS), Cortical porosity(CP).
- Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh [Month 36]
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Wall Thickness (WTh), Osteoid Thickness (OTh), Trabecular Thickness (TbTh), Trabecular Separation (TbSp) and Cortical thickness (CTh). Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest.
- Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh [Month 60]
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: WTh, OTh, TbTh, TbSp and CTh. Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest.
- Bone Histomorphometric Indices at Month 36: Total Surface (Goldner Slide) [TSG] [Month 36]
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Total Surface (Goldner Slide) [TSG]. All specimens were demineralized and subjected to staining procedures (Goldner's staining). Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm^2 and expressed as percent (%) of the total surface.
- Bone Histomorphometric Indices at Month 60: TSG [Month 60]
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Total Surface (Goldner Slide) [TSG]. All specimens were demineralized and subjected to staining procedures (Goldner's staining). Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm^2 and expressed as percent (%) of the total surface.
- Bone Histomorphometric Indices at Month 36: TtAr [Month 36]
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated variable: Tissue Area (TtAr). Tissue area comprised of the porous calcified substance from which bones were made.
- Bone Histomorphometric Indices at Month 60: TtAr [Month 60]
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated variable: Tissue Area (TtAr). Tissue area comprised of the porous calcified substance from which bones were made.
- Bone Histomorphometric Indices at Month 36: BFP, RP and RmP [Month 36]
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Bone Formation Period (BFP), Resorption Period (RP), Remodeling Period (RmP).
- Bone Histomorphometric Indices at Month 60: BFP, RP and RmP [Month 60]
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Bone Formation Period (BFP), Resorption Period (RP), Remodeling Period (RmP).
- Bone Histomorphometric Indices at Month 36: SuD [Month 36]
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Surface Density (SuD).
- Bone Histomorphometric Indices at Month 60: SuD [Month 60]
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Surface Density (SuD).
- Bone Histomorphometric Indices at Month 36: BFRTS [Month 36]
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS). BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR).
- Bone Histomorphometric Indices at Month 60: BFRTS [Month 60]
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS). BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR).
- Bone Histomorphometric Indices at Month 36: ACF [Month 36]
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF). The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP. The number of times per year that this spot begins the FP is the activation frequency (ACF).
- Bone Histomorphometric Indices at Month 60: ACF [Month 60]
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF). The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP. The number of times per year that this spot begins the FP is the activation frequency (ACF).
- Bone Histomorphometric Indices at Month 36: Mlt [Month 36]
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineralization Lag Time (Mlt). Mineralization lag time was the lag between the time osteoid was formed and the mineral was added.
- Bone Histomorphometric Indices at Month 60: Mlt [Month 60]
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineralization Lag Time (Mlt). Mineralization lag time was the lag between the time osteoid was formed and the mineral was added.
- Bone Histomorphometric Indices at Month 36: MAR [Month 36]
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineral Apposition Rate (MAR). MAR is the area of new bone formed during the label interval.
- Bone Histomorphometric Indices at Month 60: MAR [Month 60]
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineral Apposition Rate (MAR). MAR is the area of new bone formed during the label interval.
- Bone Histomorphometric Indices at Month 36: TbN [Month 36]
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Trabecular Number (TbN). TbN= Ratio of bone volume to tissue volume divided by trabecular thickness.
- Bone Histomorphometric Indices at Month 60: TbN [Month 60]
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Trabecular Number (TbN). TbN= Ratio of bone volume to tissue volume divided by trabecular thickness.
- Bone Histomorphometric Indices at Month 36: BFRBV [Month 36]
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV). BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR).
- Bone Histomorphometric Indices at Month 60: BFRBV [Month 60]
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV). BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR).
- Women's Health Questionnaire (WHQ) [Baseline]
WHQ is a measure of mid-aged women's emotional and physical health. Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness. Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes). Domain subscale score was calculated as sum of domain items score divided by number of domain items. Total score was calculated as the sum of individual domain subscale score divided by number of domains. Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction. Baseline values at different time points were considered only for the participants who were evaluable at those time points.
- Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36 [Baseline, Months 12, 24, 36]
WHQ is a measure of mid-aged women's emotional and physical health. Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness. Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes). Domain subscale score was calculated as sum of domain items score divided by number of domain items. Total score was calculated as the sum of individual domain subscale score divided by number of domains. Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction.Baseline values at different time points were considered only for the participants who were evaluable at those time points.
- European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) [Baseline]
QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. Baseline values at different time points were considered only for the participants who were evaluable at those time points.
- Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36 [Baseline, Months 12, 24, 36]
QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. Baseline values at different time points were considered only for the participants who were evaluable at those time points.
- Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) [Baseline]
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points.
- Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36 [Baseline, Months 12, 24, 36]
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points.
- Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score [Baseline]
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points.
- Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36 [Baseline, Months 12, 24, 36]
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points.
Eligibility Criteria
Criteria
Ages Eligible for Study:
55 Years
to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Must be at least 2 years postmenopausal
-
Osteoporotic subjects without vertebral fracture who meet BMD criteria, or Osteoporotic subjects with vertebral fracture
Exclusion Criteria:
-
Diseases that may affect bone metabolism
-
Vasomotor symptoms requiring treatment
-
Known history or suspected cancer of the breast
-
Active or past history of venous thromboembolic events
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Birmingham | Alabama | United States | 35233 |
| 2 | Pfizer Investigational Site | Birmingham | Alabama | United States | 35249-7201 |
| 3 | Pfizer Investigational Site | Birmingham | Alabama | United States | 35294-3708 |
| 4 | Pfizer Investigational Site | Huntsville | Alabama | United States | 35801 |
| 5 | Pfizer Investigational Site | Mobile | Alabama | United States | 36608 |
| 6 | Pfizer Investigational Site | Glendale | Arizona | United States | 85306 |
| 7 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85007 |
| 8 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85013-3903 |
| 9 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85013 |
| 10 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85015 |
| 11 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85016 |
| 12 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85020 |
| 13 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85027 |
| 14 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85050 |
| 15 | Pfizer Investigational Site | Scottsdale | Arizona | United States | 85251 |
| 16 | Pfizer Investigational Site | Scottsdale | Arizona | United States | 85254 |
| 17 | Pfizer Investigational Site | Anaheim | California | United States | 92801 |
| 18 | Pfizer Investigational Site | Berkeley | California | United States | 94705 |
| 19 | Pfizer Investigational Site | Beverly Hills | California | United States | 90211 |
| 20 | Pfizer Investigational Site | Fresno | California | United States | 93710 |
| 21 | Pfizer Investigational Site | Fresno | California | United States | 93720 |
| 22 | Pfizer Investigational Site | La Jolla | California | United States | 92037 |
| 23 | Pfizer Investigational Site | Oakland | California | United States | 94612 |
| 24 | Pfizer Investigational Site | Palm Desert | California | United States | 92260 |
| 25 | Pfizer Investigational Site | Palm Springs | California | United States | 92260 |
| 26 | Pfizer Investigational Site | Palm Springs | California | United States | 92262 |
| 27 | Pfizer Investigational Site | Palm Springs | California | United States | 92263 |
| 28 | Pfizer Investigational Site | Rancho Mirage | California | United States | 92270 |
| 29 | Pfizer Investigational Site | Sacramento | California | United States | 95816 |
| 30 | Pfizer Investigational Site | Sacramento | California | United States | 95817 |
| 31 | Pfizer Investigational Site | Sacramento | California | United States | 95825 |
| 32 | Pfizer Investigational Site | San Diego | California | United States | 92108 |
| 33 | Pfizer Investigational Site | San Diego | California | United States | 92120 |
| 34 | Pfizer Investigational Site | Upland | California | United States | 91786 |
| 35 | Pfizer Investigational Site | Whittier | California | United States | 90602 |
| 36 | Pfizer Investigational Site | Lakewood | Colorado | United States | 80227 |
| 37 | Pfizer Investigational Site | Longmont | Colorado | United States | 80501 |
| 38 | Pfizer Investigational Site | Wheat Ridge | Colorado | United States | 80033 |
| 39 | Pfizer Investigational Site | Bridgeport | Connecticut | United States | 06606 |
| 40 | Pfizer Investigational Site | Hamden | Connecticut | United States | 06518 |
| 41 | Pfizer Investigational Site | Madison | Connecticut | United States | 06443 |
| 42 | Pfizer Investigational Site | Waterbury | Connecticut | United States | 06708 |
| 43 | Pfizer Investigational Site | Newark | Delaware | United States | 19713 |
| 44 | Pfizer Investigational Site | Washington | District of Columbia | United States | 20006 |
| 45 | Pfizer Investigational Site | Washington | District of Columbia | United States | 20007-2197 |
| 46 | Pfizer Investigational Site | Washington | District of Columbia | United States | 20007 |
| 47 | Pfizer Investigational Site | Washington | District of Columbia | United States | 20037 |
| 48 | Pfizer Investigational Site | Aventura | Florida | United States | 33180 |
| 49 | Pfizer Investigational Site | Boca Raton | Florida | United States | 33432 |
| 50 | Pfizer Investigational Site | Cape Coral | Florida | United States | 33990 |
| 51 | Pfizer Investigational Site | Clearwater | Florida | United States | 33761 |
| 52 | Pfizer Investigational Site | Daytona Beach | Florida | United States | 32114 |
| 53 | Pfizer Investigational Site | Daytona Beach | Florida | United States | 32117 |
| 54 | Pfizer Investigational Site | Delray Beach | Florida | United States | 33484 |
| 55 | Pfizer Investigational Site | Fort Myers | Florida | United States | 33919 |
| 56 | Pfizer Investigational Site | Ft. Myers | Florida | United States | 33916 |
| 57 | Pfizer Investigational Site | Gainesville | Florida | United States | 32601 |
| 58 | Pfizer Investigational Site | Holiday | Florida | United States | 34690 |
| 59 | Pfizer Investigational Site | Lake Worth | Florida | United States | 33461 |
| 60 | Pfizer Investigational Site | Largo | Florida | United States | 33773 |
| 61 | Pfizer Investigational Site | Ormond Beach | Florida | United States | 32174 |
| 62 | Pfizer Investigational Site | Palm Beach Gardens | Florida | United States | 33410 |
| 63 | Pfizer Investigational Site | Palm Harbor | Florida | United States | 34684 |
| 64 | Pfizer Investigational Site | Pembroke Pines | Florida | United States | 33027 |
| 65 | Pfizer Investigational Site | Pembroke Pines | Florida | United States | 33029 |
| 66 | Pfizer Investigational Site | Plantation | Florida | United States | 33324 |
| 67 | Pfizer Investigational Site | Port Orange | Florida | United States | 32127 |
| 68 | Pfizer Investigational Site | Sarasota | Florida | United States | 34231 |
| 69 | Pfizer Investigational Site | Sarasota | Florida | United States | 34239 |
| 70 | Pfizer Investigational Site | St Petersburg | Florida | United States | 33710 |
| 71 | Pfizer Investigational Site | West Palm Beach | Florida | United States | 33401 |
| 72 | Pfizer Investigational Site | West Palm Beach | Florida | United States | 33407 |
| 73 | Pfizer Investigational Site | West Palm Beach | Florida | United States | 33409 |
| 74 | Pfizer Investigational Site | West Palm Beach | Florida | United States | 33417 |
| 75 | Pfizer Investigational Site | Augusta | Georgia | United States | 30909 |
| 76 | Pfizer Investigational Site | Decatur | Georgia | United States | 30033 |
| 77 | Pfizer Investigational Site | Riverdale | Georgia | United States | 30274 |
| 78 | Pfizer Investigational Site | Boise | Idaho | United States | 83702 |
| 79 | Pfizer Investigational Site | Boise | Idaho | United States | 83704 |
| 80 | Pfizer Investigational Site | Boise | Idaho | United States | 83712 |
| 81 | Pfizer Investigational Site | Cadwell | Idaho | United States | 83605 |
| 82 | Pfizer Investigational Site | Idaho Falls | Idaho | United States | 83404 |
| 83 | Pfizer Investigational Site | Meridian | Idaho | United States | 83642 |
| 84 | Pfizer Investigational Site | Champaign | Illinois | United States | 61820 |
| 85 | Pfizer Investigational Site | Chicago | Illinois | United States | 60612 |
| 86 | Pfizer Investigational Site | Libertyville | Illinois | United States | 60048 |
| 87 | Pfizer Investigational Site | Peoria | Illinois | United States | 61614 |
| 88 | Pfizer Investigational Site | Avon | Indiana | United States | 46123 |
| 89 | Pfizer Investigational Site | Evansville | Indiana | United States | 47712 |
| 90 | Pfizer Investigational Site | Evansville | Indiana | United States | 47714 |
| 91 | Pfizer Investigational Site | Evansville | Indiana | United States | 47750 |
| 92 | Pfizer Investigational Site | Kansas City | Kansas | United States | 66160-7136 |
| 93 | Pfizer Investigational Site | Louisville | Kentucky | United States | 40207 |
| 94 | Pfizer Investigational Site | Louisville | Kentucky | United States | 40291 |
| 95 | Pfizer Investigational Site | Lousiville | Kentucky | United States | 40291 |
| 96 | Pfizer Investigational Site | Bangor | Maine | United States | 04401 |
| 97 | Pfizer Investigational Site | Bangor | Maine | United States | 4401 |
| 98 | Pfizer Investigational Site | Bethesda | Maryland | United States | 20817 |
| 99 | Pfizer Investigational Site | Silver Spring | Maryland | United States | 20902 |
| 100 | Pfizer Investigational Site | Wheaton | Maryland | United States | 20902 |
| 101 | Pfizer Investigational Site | Boston | Massachusetts | United States | 02115 |
| 102 | Pfizer Investigational Site | Brookline | Massachusetts | United States | 02445 |
| 103 | Pfizer Investigational Site | Fall River | Massachusetts | United States | 02720 |
| 104 | Pfizer Investigational Site | Fall River | Massachusetts | United States | 02721 |
| 105 | Pfizer Investigational Site | Grand Rapids | Michigan | United States | 49503 |
| 106 | Pfizer Investigational Site | Grand Rapids | Michigan | United States | 49546 |
| 107 | Pfizer Investigational Site | Kalamazaoo | Michigan | United States | 49048 |
| 108 | Pfizer Investigational Site | Kalamazoo | Michigan | United States | 49048 |
| 109 | Pfizer Investigational Site | Brooklyn Center | Minnesota | United States | 55430 |
| 110 | Pfizer Investigational Site | Robbinsdale | Minnesota | United States | 55422 |
| 111 | Pfizer Investigational Site | Shoreview | Minnesota | United States | 55126 |
| 112 | Pfizer Investigational Site | Flowood | Mississippi | United States | 39232 |
| 113 | Pfizer Investigational Site | Jackson | Mississippi | United States | 39216 |
| 114 | Pfizer Investigational Site | Jefferson City | Missouri | United States | 65109 |
| 115 | Pfizer Investigational Site | St Louis | Missouri | United States | 63141 |
| 116 | Pfizer Investigational Site | St. Louis | Missouri | United States | 63141 |
| 117 | Pfizer Investigational Site | Billings | Montana | United States | 59101 |
| 118 | Pfizer Investigational Site | Bozeman | Montana | United States | 59715 |
| 119 | Pfizer Investigational Site | Missoula | Montana | United States | 59801 |
| 120 | Pfizer Investigational Site | Missoula | Montana | United States | 59802 |
| 121 | Pfizer Investigational Site | Missoula | Montana | United States | 59804 |
| 122 | Pfizer Investigational Site | Lincoln | Nebraska | United States | 68510 |
| 123 | Pfizer Investigational Site | Henderson | Nevada | United States | 89014 |
| 124 | Pfizer Investigational Site | North Las Vegas | Nevada | United States | 89030 |
| 125 | Pfizer Investigational Site | Reno | Nevada | United States | 89502-1196 |
| 126 | Pfizer Investigational Site | Reno | Nevada | United States | 89503 |
| 127 | Pfizer Investigational Site | Manchester Twp | New Jersey | United States | 08759 |
| 128 | Pfizer Investigational Site | Ocean | New Jersey | United States | 07712 |
| 129 | Pfizer Investigational Site | Princeton | New Jersey | United States | 08542 |
| 130 | Pfizer Investigational Site | Albuquerque | New Mexico | United States | 87102 |
| 131 | Pfizer Investigational Site | Albuquerque | New Mexico | United States | 87106 |
| 132 | Pfizer Investigational Site | Albuquerque | New Mexico | United States | 87109 |
| 133 | Pfizer Investigational Site | Bronx | New York | United States | 10461 |
| 134 | Pfizer Investigational Site | New Hyde Park | New York | United States | 11042 |
| 135 | Pfizer Investigational Site | New York | New York | United States | 10029 |
| 136 | Pfizer Investigational Site | Charlotte | North Carolina | United States | 28207 |
| 137 | Pfizer Investigational Site | Charlotte | North Carolina | United States | 28209 |
| 138 | Pfizer Investigational Site | Charlotte | North Carolina | United States | 28277 |
| 139 | Pfizer Investigational Site | Winston-Salem | North Carolina | United States | 27103 |
| 140 | Pfizer Investigational Site | Bismarck | North Dakota | United States | 58501 |
| 141 | Pfizer Investigational Site | Bismark | North Dakota | United States | 58501 |
| 142 | Pfizer Investigational Site | Bismark | North Dakota | United States | 58503 |
| 143 | Pfizer Investigational Site | Fargo | North Dakota | United States | 58103 |
| 144 | Pfizer Investigational Site | Fargo | North Dakota | United States | 58104 |
| 145 | Pfizer Investigational Site | Jamestown | North Dakota | United States | 58401 |
| 146 | Pfizer Investigational Site | Minot | North Dakota | United States | 58701 |
| 147 | Pfizer Investigational Site | Minot | North Dakota | United States | 58702 |
| 148 | Pfizer Investigational Site | Oakes | North Dakota | United States | 58574 |
| 149 | Pfizer Investigational Site | Akron | Ohio | United States | 44312-1647 |
| 150 | Pfizer Investigational Site | Akron | Ohio | United States | 44313 |
| 151 | Pfizer Investigational Site | Centerville | Ohio | United States | 45459 |
| 152 | Pfizer Investigational Site | Cincinnati | Ohio | United States | 45236 |
| 153 | Pfizer Investigational Site | Cincinnati | Ohio | United States | 45249 |
| 154 | Pfizer Investigational Site | Cleveland | Ohio | United States | 44122 |
| 155 | Pfizer Investigational Site | Kettering | Ohio | United States | 45459 |
| 156 | Pfizer Investigational Site | Lyndhurst | Ohio | United States | 44124 |
| 157 | Pfizer Investigational Site | Mayfield Village | Ohio | United States | 44143 |
| 158 | Pfizer Investigational Site | Oklahoma City | Oklahoma | United States | 73112-4481 |
| 159 | Pfizer Investigational Site | Oklahoma City | Oklahoma | United States | 73142 |
| 160 | Pfizer Investigational Site | Oklahoma | Oklahoma | United States | 73102 |
| 161 | Pfizer Investigational Site | Oklahoma | Oklahoma | United States | 73120 |
| 162 | Pfizer Investigational Site | Tulsa | Oklahoma | United States | 74135 |
| 163 | Pfizer Investigational Site | Yukon | Oklahoma | United States | 73099 |
| 164 | Pfizer Investigational Site | Altoona | Pennsylvania | United States | 16602 |
| 165 | Pfizer Investigational Site | Camp Hill | Pennsylvania | United States | 17011 |
| 166 | Pfizer Investigational Site | Duncansville | Pennsylvania | United States | 16635 |
| 167 | Pfizer Investigational Site | Johnstown | Pennsylvania | United States | 15904 |
| 168 | Pfizer Investigational Site | Langhome | Pennsylvania | United States | 19047 |
| 169 | Pfizer Investigational Site | Lemoyne | Pennsylvania | United States | 17043 |
| 170 | Pfizer Investigational Site | Newtown | Pennsylvania | United States | 18940 |
| 171 | Pfizer Investigational Site | Sellersville | Pennsylvania | United States | 18960 |
| 172 | Pfizer Investigational Site | West Reading | Pennsylvania | United States | 19611 |
| 173 | Pfizer Investigational Site | Wyomissing | Pennsylvania | United States | 19610 |
| 174 | Pfizer Investigational Site | Anderson | South Carolina | United States | 29621 |
| 175 | Pfizer Investigational Site | Belton | South Carolina | United States | 29627 |
| 176 | Pfizer Investigational Site | Mt. Pleasant | South Carolina | United States | 29464 |
| 177 | Pfizer Investigational Site | Aberdeen | South Dakota | United States | 57401 |
| 178 | Pfizer Investigational Site | Sioux Falls | South Dakota | United States | 57105 |
| 179 | Pfizer Investigational Site | Waterdown | South Dakota | United States | 57201 |
| 180 | Pfizer Investigational Site | Watertown | South Dakota | United States | 57201 |
| 181 | Pfizer Investigational Site | Memphis | Tennessee | United States | 38104 |
| 182 | Pfizer Investigational Site | Memphis | Tennessee | United States | 38119 |
| 183 | Pfizer Investigational Site | Memphis | Tennessee | United States | 38120 |
| 184 | Pfizer Investigational Site | Memphis | Tennessee | United States | 38138 |
| 185 | Pfizer Investigational Site | Nashville | Tennessee | United States | 37203 |
| 186 | Pfizer Investigational Site | Bellaire | Texas | United States | 77401 |
| 187 | Pfizer Investigational Site | Dallas | Texas | United States | 75230-2513 |
| 188 | Pfizer Investigational Site | Dallas | Texas | United States | 75230 |
| 189 | Pfizer Investigational Site | Dallas | Texas | United States | 75231 |
| 190 | Pfizer Investigational Site | Dallas | Texas | United States | 75243 |
| 191 | Pfizer Investigational Site | Houston | Texas | United States | 77030 |
| 192 | Pfizer Investigational Site | San Antonio | Texas | United States | 78220 |
| 193 | Pfizer Investigational Site | San Antonio | Texas | United States | 78229-3894 |
| 194 | Pfizer Investigational Site | San Antonio | Texas | United States | 78229 |
| 195 | Pfizer Investigational Site | Temple | Texas | United States | 76504 |
| 196 | Pfizer Investigational Site | Waco | Texas | United States | 76708 |
| 197 | Pfizer Investigational Site | Salt Lake City | Utah | United States | 84102-3015 |
| 198 | Pfizer Investigational Site | Norfolk | Virginia | United States | 23502 |
| 199 | Pfizer Investigational Site | Virginia Beach | Virginia | United States | 23454 |
| 200 | Pfizer Investigational Site | Seattle | Washington | United States | 98105-4631 |
| 201 | Pfizer Investigational Site | Seattle | Washington | United States | 98105 |
| 202 | Pfizer Investigational Site | Seattle | Washington | United States | 98133 |
| 203 | Pfizer Investigational Site | Seattle | Washington | United States | 98195 |
| 204 | Pfizer Investigational Site | Spokane | Washington | United States | 99204 |
| 205 | Pfizer Investigational Site | Milwaukee | Wisconsin | United States | 53209 |
| 206 | Pfizer Investigational Site | Milwaukee | Wisconsin | United States | 53226 |
| 207 | Pfizer Investigational Site | Cheyenne | Wyoming | United States | 82001 |
| 208 | Pfizer Investigational Site | Provincia de Buenos Aires | Argentina | ||
| 209 | Pfizer Investigational Site | Concord | New South Wales | Australia | 2139 |
| 210 | Pfizer Investigational Site | St Leonards | New South Wales | Australia | 2065 |
| 211 | Pfizer Investigational Site | Nedlands | Western Australia | Australia | 6009 |
| 212 | Pfizer Investigational Site | Herston | Australia | QLD 4029 | |
| 213 | Pfizer Investigational Site | Keswick | Australia | ||
| 214 | Pfizer Investigational Site | Graz | Austria | 8036 | |
| 215 | Pfizer Investigational Site | Diepenbeek | Belgium | 3590 | |
| 216 | Pfizer Investigational Site | Genk | Belgium | 3600 | |
| 217 | Pfizer Investigational Site | Gent | Belgium | 9000 | |
| 218 | Pfizer Investigational Site | Leuven | Belgium | 3000 | |
| 219 | Pfizer Investigational Site | Liege | Belgium | 4000 | |
| 220 | Pfizer Investigational Site | Schiepsebos | Belgium | 6 | |
| 221 | Pfizer Investigational Site | Goiania | GO | Brazil | 74175-080 |
| 222 | Pfizer Investigational Site | Duque de Caxias - Cuiaba | MT | Brazil | 78043-306 |
| 223 | Pfizer Investigational Site | Rio de Janeiro | RJ | Brazil | 20020-020 |
| 224 | Pfizer Investigational Site | Rio de Janeiro | RJ | Brazil | 22271-100 |
| 225 | Pfizer Investigational Site | Sorocaba | Sao Paulo | Brazil | 18095-450 |
| 226 | Pfizer Investigational Site | São Paulo | SP | Brazil | 04020-060 |
| 227 | Pfizer Investigational Site | Pleven | Bulgaria | 5800 | |
| 228 | Pfizer Investigational Site | Plovdiv | Bulgaria | 4002 | |
| 229 | Pfizer Investigational Site | Sofia | Bulgaria | 1301 | |
| 230 | Pfizer Investigational Site | Sofia | Bulgaria | 1303 | |
| 231 | Pfizer Investigational Site | Sofia | Bulgaria | 1407 | |
| 232 | Pfizer Investigational Site | Sofia | Bulgaria | 1431 | |
| 233 | Pfizer Investigational Site | Sofia | Bulgaria | 1504 | |
| 234 | Pfizer Investigational Site | Calgary | Alberta | Canada | T2N 4Z6 |
| 235 | Pfizer Investigational Site | Vancouver | British Columbia | Canada | V5Z 2N6 |
| 236 | Pfizer Investigational Site | Vancouver | British Columbia | Canada | V6H 3X8 |
| 237 | Pfizer Investigational Site | Winnipeg | Manitoba | Canada | R3A 1M3 |
| 238 | Pfizer Investigational Site | Hamilton | Ontario | Canada | L8N 1Y2 |
| 239 | Pfizer Investigational Site | Hawkesbury | Ontario | Canada | K6A 1A1 |
| 240 | Pfizer Investigational Site | Hawkesbury | Ontario | Canada | K6A 3B2 |
| 241 | Pfizer Investigational Site | London | Ontario | Canada | N6A 4V2 |
| 242 | Pfizer Investigational Site | Toronto | Ontario | Canada | M5C 1R6 |
| 243 | Pfizer Investigational Site | Toronto | Ontario | Canada | M5C 2T2 |
| 244 | Pfizer Investigational Site | Toronto | Ontario | Canada | M5G 1E2 |
| 245 | Pfizer Investigational Site | Toronto | Ontario | Canada | MB5 1W8 |
| 246 | Pfizer Investigational Site | Gatineau | Quebec | Canada | J8Y 6S9 |
| 247 | Pfizer Investigational Site | Montreal | Quebec | Canada | H2L 1S6 |
| 248 | Pfizer Investigational Site | Montreal | Quebec | Canada | H2X 1N8 |
| 249 | Pfizer Investigational Site | Pointe-Claire | Quebec | Canada | H9R 4S3 |
| 250 | Pfizer Investigational Site | Sherbrooke | Quebec | Canada | J1H 4J6 |
| 251 | Pfizer Investigational Site | Trois-Rivieres | Quebec | Canada | G8Z 1Y2 |
| 252 | Pfizer Investigational Site | Saskatoon | Saskatchewan | Canada | S7K 0H6 |
| 253 | Pfizer Investigational Site | Saskatoon | Saskatchewan | Canada | S7K 1N4 |
| 254 | Pfizer Investigational Site | Quebec | Canada | G1S 2L6 | |
| 255 | Pfizer Investigational Site | Quebec | Canada | G1V 3M7 | |
| 256 | Pfizer Investigational Site | Santiago | Chile | ||
| 257 | Pfizer Investigational Site | Zadar | Croatia | 23000 | |
| 258 | Pfizer Investigational Site | Zagreb | Croatia | 10000 | |
| 259 | Pfizer Investigational Site | Aalborg | Denmark | 9000 | |
| 260 | Pfizer Investigational Site | Ballerup | Denmark | 2750 | |
| 261 | Pfizer Investigational Site | Vejle | Denmark | 7100 | |
| 262 | Pfizer Investigational Site | Tallinn | Estonia | 10128 | |
| 263 | Pfizer Investigational Site | Tartu | Estonia | 50410 | |
| 264 | Pfizer Investigational Site | Tartu | Estonia | 51010 | |
| 265 | Pfizer Investigational Site | Tartu | Estonia | ||
| 266 | Pfizer Investigational Site | Jyvaskyla | FIN | Finland | 40100 |
| 267 | Pfizer Investigational Site | Jyvaskyla | Finland | FIN-40100 | |
| 268 | Pfizer Investigational Site | Jyväskylä | Finland | 40700 | |
| 269 | Pfizer Investigational Site | Kuopio | Finland | 70210 | |
| 270 | Pfizer Investigational Site | Kuopio | Finland | 70211 | |
| 271 | Pfizer Investigational Site | Kuopio | Finland | FIN-70211 | |
| 272 | Pfizer Investigational Site | Lahti | Finland | ||
| 273 | Pfizer Investigational Site | Oulu | Finland | 90 100 | |
| 274 | Pfizer Investigational Site | Turku | Finland | 20100 | |
| 275 | Pfizer Investigational Site | Lyon Cedex 03 | France | 69437 | |
| 276 | Pfizer Investigational Site | Orleans cedex 1 | France | 45032 | |
| 277 | Pfizer Investigational Site | Paris | France | 75015 | |
| 278 | Pfizer Investigational Site | Berlin | Germany | 12200 | |
| 279 | Pfizer Investigational Site | Muenchen | Germany | 80809 | |
| 280 | Pfizer Investigational Site | Zerbst | Germany | 39261 | |
| 281 | Pfizer Investigational Site | Athens | Greece | 11526 | |
| 282 | Pfizer Investigational Site | Hong Kong | Hong Kong | ||
| 283 | Pfizer Investigational Site | PRC | Hong Kong | ||
| 284 | Pfizer Investigational Site | Sai Ying Pung | Hong Kong | ||
| 285 | Pfizer Investigational Site | Bekescsaba | Hungary | 5600 | |
| 286 | Pfizer Investigational Site | H-6720 Szeged | Hungary | ||
| 287 | Pfizer Investigational Site | Kecskemet | Hungary | 6000 | |
| 288 | Pfizer Investigational Site | Mako | Hungary | 6900 | |
| 289 | Pfizer Investigational Site | Roma | Italy | 00136 | |
| 290 | Pfizer Investigational Site | Roma | Italy | 00168 | |
| 291 | Pfizer Investigational Site | Roma | Italy | 00189 | |
| 292 | Pfizer Investigational Site | Siena | Italy | 53100 | |
| 293 | Pfizer Investigational Site | Kaunas | Lithuania | LT-50009 | |
| 294 | Pfizer Investigational Site | Vilnius | Lithuania | LT-04130 | |
| 295 | Pfizer Investigational Site | Vilnius | Lithuania | LT-10318 | |
| 296 | Pfizer Investigational Site | seccion de Lomas Verdes | Estado de Mexico | Mexico | CP 53120 |
| 297 | Pfizer Investigational Site | Mexico City | Mexico | 03100 | |
| 298 | Pfizer Investigational Site | Mexico D.F. | Mexico | 11800 | |
| 299 | Pfizer Investigational Site | Emmen | Dr | Netherlands | 7824 AA |
| 300 | Pfizer Investigational Site | Nijmegen | GA | Netherlands | 6525 |
| 301 | Pfizer Investigational Site | Amsterdam | HV | Netherlands | 1081 |
| 302 | Pfizer Investigational Site | Nijmegen | SZ | Netherlands | 6532 |
| 303 | Pfizer Investigational Site | Eindhoven | Netherlands | 5611 NJ | |
| 304 | Pfizer Investigational Site | Rotterdam | Netherlands | 3001 HG | |
| 305 | Pfizer Investigational Site | Milford | Auckland | New Zealand | |
| 306 | Pfizer Investigational Site | Christchurch | NZ | New Zealand | 8143 |
| 307 | Pfizer Investigational Site | Auckland | New Zealand | ||
| 308 | Pfizer Investigational Site | Dunedin | New Zealand | ||
| 309 | Pfizer Investigational Site | Bergen | Norway | NO-5094 | |
| 310 | Pfizer Investigational Site | Hamar | Norway | 2317 | |
| 311 | Pfizer Investigational Site | Oslo | Norway | NO-0164 | |
| 312 | Pfizer Investigational Site | Oslo | Norway | NO-0176 | |
| 313 | Pfizer Investigational Site | Trondheim | Norway | 7006 | |
| 314 | Pfizer Investigational Site | Trondheim | Norway | NO-7006 | |
| 315 | Pfizer Investigational Site | Katowice | Poland | 40-084 | |
| 316 | Pfizer Investigational Site | Krakow | Poland | 30-007 | |
| 317 | Pfizer Investigational Site | Krakow | Poland | 30-017 | |
| 318 | Pfizer Investigational Site | Krakow | Poland | 30-224 | |
| 319 | Pfizer Investigational Site | Krakow | Poland | 30-510 | |
| 320 | Pfizer Investigational Site | Krakow | Poland | 31-501 | |
| 321 | Pfizer Investigational Site | Lublin | Poland | 20-090 | |
| 322 | Pfizer Investigational Site | Warszawa | Poland | 00-315 | |
| 323 | Pfizer Investigational Site | Warszawa | Poland | 00-418 | |
| 324 | Pfizer Investigational Site | Warszawa | Poland | 00-655 | |
| 325 | Pfizer Investigational Site | Warszawa | Poland | 00-699 | |
| 326 | Pfizer Investigational Site | Warszawa | Poland | 00-909 | |
| 327 | Pfizer Investigational Site | Warszawa | Poland | 02-341 | |
| 328 | Pfizer Investigational Site | Warszawa | Poland | 02-796 | |
| 329 | Pfizer Investigational Site | Warszawa | Poland | 03-335 | |
| 330 | Pfizer Investigational Site | Warszawa | Poland | 04-730 | |
| 331 | Pfizer Investigational Site | Wroclaw | Poland | 50-088 | |
| 332 | Pfizer Investigational Site | Cluj- | Napoca | Romania | 400000 |
| 333 | Pfizer Investigational Site | Bucharesti | Romania | 7000 | |
| 334 | Pfizer Investigational Site | Bucharest | Romania | 7000 | |
| 335 | Pfizer Investigational Site | Bucuresti | Romania | 050521 | |
| 336 | Pfizer Investigational Site | Bucuresti | Romania | 70231 | |
| 337 | Pfizer Investigational Site | Cluj-Napoca | Romania | 400349 | |
| 338 | Pfizer Investigational Site | Iasi | Romania | 700111 | |
| 339 | Pfizer Investigational Site | Moscow | Russian Federation | 101990 | |
| 340 | Pfizer Investigational Site | Moscow | Russian Federation | 107014 | |
| 341 | Pfizer Investigational Site | Moscow | Russian Federation | 115522 | |
| 342 | Pfizer Investigational Site | Moscow | Russian Federation | 117036 | |
| 343 | Pfizer Investigational Site | Moscow | Russian Federation | 119002 | |
| 344 | Pfizer Investigational Site | Moscow | Russian Federation | 121356 | |
| 345 | Pfizer Investigational Site | Moscow | Russian Federation | 127299 | |
| 346 | Pfizer Investigational Site | Moscow | Russian Federation | 129010 | |
| 347 | Pfizer Investigational Site | Saint Petersburg | Russian Federation | 190068 | |
| 348 | Pfizer Investigational Site | St Petersburg | Russian Federation | 194291 | |
| 349 | Pfizer Investigational Site | St. Petersburg | Russian Federation | 1190068 | |
| 350 | Pfizer Investigational Site | St. Petersburg | Russian Federation | 190068 | |
| 351 | Pfizer Investigational Site | St. Petersburg | Russian Federation | 199034 | |
| 352 | Pfizer Investigational Site | Piestany | Slovak Republic | Slovakia | |
| 353 | Pfizer Investigational Site | Bratislava | Slovakia | 826 06 | |
| 354 | Pfizer Investigational Site | Bratislava | Slovakia | 833 01 | |
| 355 | Pfizer Investigational Site | Bratislava | Slovakia | 83301 | |
| 356 | Pfizer Investigational Site | Bratislava | Slovakia | 851 07 | |
| 357 | Pfizer Investigational Site | Groenkloof, 0181 | Pretoria | South Africa | |
| 358 | Pfizer Investigational Site | Bedford Gardens | South Africa | ||
| 359 | Pfizer Investigational Site | Johannesburg 2193 | South Africa | ||
| 360 | Pfizer Investigational Site | Johannesburg, 2193 | South Africa | ||
| 361 | Pfizer Investigational Site | Johannesburg | South Africa | 2193 | |
| 362 | Pfizer Investigational Site | Johannesburg | South Africa | 2196 | |
| 363 | Pfizer Investigational Site | Parow 7500 | South Africa | ||
| 364 | Pfizer Investigational Site | Parow | South Africa | 7500 | |
| 365 | Pfizer Investigational Site | Pretoria, 0042 | South Africa | ||
| 366 | Pfizer Investigational Site | Pretoria, 0181 | South Africa | ||
| 367 | Pfizer Investigational Site | Pretoria | South Africa | 0042 | |
| 368 | Pfizer Investigational Site | Pretoria | South Africa | 0181 | |
| 369 | Pfizer Investigational Site | Somerset West, 7129 | South Africa | ||
| 370 | Pfizer Investigational Site | Somerset West, 7130 | South Africa | ||
| 371 | Pfizer Investigational Site | Somerset West | South Africa | ||
| 372 | Pfizer Investigational Site | Stellenbosch 7600 | South Africa | ||
| 373 | Pfizer Investigational Site | Madrid | Spain | 28006 | |
| 374 | Pfizer Investigational Site | Madrid | Spain | 28009 | |
| 375 | Pfizer Investigational Site | Madrid | Spain | 28040 | |
| 376 | Pfizer Investigational Site | Madrid | Spain | 28046 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00205777
Other Study ID Numbers:
- 3068A1-301
- B1781001
First Posted:
Sep 20, 2005
Last Update Posted:
Apr 10, 2013
Last Verified:
Feb 1, 2013
Keywords provided by Pfizer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) | Bazedoxifene 20 mg (SE II) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 milligram (mg) capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Period Title: Core Study (Up to 3 Years) | ||||||
| STARTED | 1907 | 1904 | 1884 | 1914 | 0 | 0 |
| TREATED | 1886 | 1872 | 1849 | 1885 | 0 | 0 |
| COMPLETED | 1279 | 1245 | 1277 | 1282 | 0 | 0 |
| NOT COMPLETED | 628 | 659 | 607 | 632 | 0 | 0 |
| Period Title: Core Study (Up to 3 Years) | ||||||
| STARTED | 1279 | 1245 | 1277 | 1282 | 0 | 0 |
| COMPLETED | 1047 | 1041 | 1070 | 1058 | 0 | 0 |
| NOT COMPLETED | 232 | 204 | 207 | 224 | 0 | 0 |
| Period Title: Core Study (Up to 3 Years) | ||||||
| STARTED | 1047 | 0 | 1070 | 1058 | 1041 | 0 |
| COMPLETED | 833 | 0 | 0 | 830 | 840 | 0 |
| NOT COMPLETED | 214 | 0 | 1070 | 228 | 201 | 0 |
| Period Title: Core Study (Up to 3 Years) | ||||||
| STARTED | 833 | 0 | 0 | 830 | 840 | 0 |
| COMPLETED | 560 | 0 | 0 | 590 | 582 | 0 |
| NOT COMPLETED | 273 | 0 | 0 | 240 | 258 | 0 |
| Period Title: Core Study (Up to 3 Years) | ||||||
| STARTED | 0 | 0 | 0 | 590 | 0 | 1142 |
| TREATED | 0 | 0 | 0 | 519 | 0 | 1011 |
| COMPLETED | 0 | 0 | 0 | 441 | 0 | 860 |
| NOT COMPLETED | 0 | 0 | 0 | 149 | 0 | 282 |
Baseline Characteristics
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Total of all reporting groups |
| Overall Participants | 1886 | 1872 | 1849 | 1885 | 7492 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
66.48
(6.53)
|
66.22
(6.80)
|
66.36
(6.74)
|
66.47
(6.76)
|
66.38
(6.71)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
1886
100%
|
1872
100%
|
1849
100%
|
1885
100%
|
7492
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Height (centimeter (cm)) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [centimeter (cm)] |
156.60
(7.21)
|
156.28
(7.38)
|
156.37
(7.23)
|
156.35
(6.90)
|
156.40
(7.18)
|
Outcome Measures
| Title | Percentage of Participants With New Vertebral Fractures Through Month 36 |
|---|---|
| Description | New vertebral fracture: decrease in anterior, mid, or posterior vertebral (vt) height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture. |
| Time Frame | Baseline through Month 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat(ITT) population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1724 | 1686 | 1696 | 1741 |
| No Prevalent Fracture (n=757,744,742,760) |
1.98
0.1%
|
2.14
0.1%
|
1.84
0.1%
|
3.13
0.2%
|
| At Least 1 Prevalent Fracture (n=967,942,954,981) |
2.63
0.1%
|
2.80
0.1%
|
2.74
0.1%
|
4.80
0.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% confidence intervals (CIs). | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.22 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.647 | |
| Confidence Interval |
(2-Sided) 95% 0.322 to 1.302 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg [Core] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.24 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.647 | |
| Confidence Interval |
(2-Sided) 95% 0.322 to 1.301 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg [Core] versus Raloxifene 60 mg [Core]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.83 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.097 | |
| Confidence Interval |
(2-Sided) 95% 0.501 to 2.405 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Raloxifene 60 mg [Core]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.87 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.074 | |
| Confidence Interval |
(2-Sided) 95% 0.490 to 2.356 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Bazedoxifene 40 mg [Core]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.96 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.988 | |
| Confidence Interval |
(2-Sided) 95% 0.458 to 2.131 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Raloxifene 60 mg [Core] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.16 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.592 | |
| Confidence Interval |
(2-Sided) 95% 0.289 to 1.212 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.035 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.551 | |
| Confidence Interval |
(2-Sided) 95% 0.324 to 0.937 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg [Core] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.070 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.624 | |
| Confidence Interval |
(2-Sided) 95% 0.373 to 1.045 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg [Core] versus Raloxifene 60 mg [Core]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.79 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.085 | |
| Confidence Interval |
(2-Sided) 95% 0.605 to 1.947 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Raloxifene 60 mg [Core]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.99 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.959 | |
| Confidence Interval |
(2-Sided) 95% 0.527 to 1.743 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Bazedoxifene 40 mg [Core]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.78 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.882 | |
| Confidence Interval |
(2-Sided) 95% 0.488 to 1.593 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Raloxifene 60 mg [Core] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.036 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.574 | |
| Confidence Interval |
(2-Sided) 95% 0.340 to 0.968 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants With New Vertebral Fractures Through Month 60 |
|---|---|
| Description | New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture. |
| Time Frame | Baseline through Month 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) |
|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1724 | 1741 | 1686 |
| No Prevalent Fracture (n=757,760,744) |
3.11
0.2%
|
5.40
0.3%
|
3.46
0.2%
|
| At Least 1 Prevalent Fracture (n=967,981,942) |
5.67
0.3%
|
7.95
0.4%
|
4.28
0.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.097 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.610 | |
| Confidence Interval |
(2-Sided) 95% 0.339 to 1.099 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40/20 mg [SE I] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.15 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.645 | |
| Confidence Interval |
(2-Sided) 95% 0.361 to 1.151 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Bazedoxifene 40/20 mg [SE I]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.83 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.941 | |
| Confidence Interval |
(2-Sided) 95% 0.493 to 1.793 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.067 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.666 | |
| Confidence Interval |
(2-Sided) 95% 0.435 to 1.019 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40/20 mg [SE I] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.014 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.573 | |
| Confidence Interval |
(2-Sided) 95% 0.367 to 0.896 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Bazedoxifene 40/20 mg [SE I]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.50 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.157 | |
| Confidence Interval |
(2-Sided) 95% 0.710 to 1.885 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants With New Vertebral Fractures Through Month 84 |
|---|---|
| Description | New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture. |
| Time Frame | Baseline through Month 84 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified ITT(mITT) population of safety population category one(SP1) population:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.N (number of participants analyzed)=participants evaluable.n=participants with specified baseline fracture status. |
| Arm/Group Title | Placebo (Core+SE I+SE II) | Bazedoxifene 20 mg (SE II) |
|---|---|---|
| Arm/Group Description | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1741 | 3410 |
| No Prevalent Fracture (n=760,1501) |
8.18
0.4%
|
5.79
0.3%
|
| At Least 1 Prevalent Fracture (n=981,1909) |
11.35
0.6%
|
6.90
0.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [SE II] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.085 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.680 | |
| Confidence Interval |
(2-Sided) 95% 0.440 to 1.052 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [SE II] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.004 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.610 | |
| Confidence Interval |
(2-Sided) 95% 0.434 to 0.857 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Incidence of Breast Cancer Through Month 36 |
|---|---|
| Description | Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time). |
| Time Frame | Baseline through Month 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population 1 (SP1) included all randomized participants who received at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1885 | 1872 | 1849 | 1885 |
| Number [Breast cancer per 1000-women years] |
1.09
|
0.90
|
1.55
|
1.74
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.40 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.621 | |
| Confidence Interval |
(2-Sided) 95% 0.203 to 1.903 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.26 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.504 | |
| Confidence Interval |
(2-Sided) 95% 0.151 to 1.676 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.33 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.540 | |
| Confidence Interval |
(2-Sided) 95% 0.157 to 1.860 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.49 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.661 | |
| Confidence Interval |
(2-Sided) 95% 0.206 to 2.118 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.76 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.850 | |
| Confidence Interval |
(2-Sided) 95% 0.305 to 2.370 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.75 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.238 | |
| Confidence Interval |
(2-Sided) 95% 0.332 to 4.616 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Incidence of Breast Cancer Through Month 60 |
|---|---|
| Description | Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time). |
| Time Frame | Baseline through Month 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SP1 included all randomized participants who received at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) |
|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1885 | 1885 | 1872 |
| Number [Breast cancer per 1000-women years] |
1.40
|
1.56
|
1.43
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Relative risk versus placebo was provided together with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Relative Risk |
| Estimated Value | 0.9 | |
| Confidence Interval |
(2-Sided) 95% 0.38 to 2.15 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Relative risk versus placebo was provided together with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Relative Risk |
| Estimated Value | 0.92 | |
| Confidence Interval |
(2-Sided) 95% 0.39 to 2.21 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Incidence of Breast Cancer Through Month 84 |
|---|---|
| Description | Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time). |
| Time Frame | Baseline through Month 84 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SP1 included all randomized participants who received at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure. |
| Arm/Group Title | Placebo (Core+SE I+SE II) | Bazedoxifene 20 mg (SE II) |
|---|---|---|
| Arm/Group Description | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1885 | 3757 |
| Number [Breast cancer per 1000-women years] |
1.50
|
1.52
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Relative risk versus placebo was provided together with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Relative risk |
| Estimated Value | 1.01 | |
| Confidence Interval |
(2-Sided) 95% 0.5 to 2.06 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants With New Clinical Vertebral Fractures Through Month 36 |
|---|---|
| Description | A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base. |
| Time Frame | Baseline through Month 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1724 | 1686 | 1696 | 1741 |
| Number (95% Confidence Interval) [Percentage of participants] |
0.72
0%
|
0.76
0%
|
0.87
0%
|
0.94
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.57 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.62 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.72 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.67 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.89 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.95 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Percentage of Participants With New Clinical Vertebral Fractures Through Month 60 |
|---|---|
| Description | A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base. |
| Time Frame | Baseline through Month 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) |
|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1724 | 1741 | 1686 |
| Number (95% Confidence Interval) [Percentage of participants] |
0.79
0%
|
1.37
0.1%
|
0.84
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.29 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.31 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.94 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Percentage of Participants With New Clinical Vertebral Fractures Through Month 84 |
|---|---|
| Description | A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base. |
| Time Frame | Baseline through Month 84 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT population of SP1 population included all randomized participants who took at least 1 dose of test article and who had a vertebral radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. |
| Arm/Group Title | Placebo (Core+SE I+SE II) | Bazedoxifene 20 mg (SE II) |
|---|---|---|
| Arm/Group Description | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1741 | 3410 |
| Number (95% Confidence Interval) [Percentage of participants] |
1.92
0.1%
|
1.28
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.18 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Number of Participants With Worsening Vertebral Fractures Through Month 36 |
|---|---|
| Description | A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline. |
| Time Frame | Baseline through Month 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1724 | 1686 | 1696 | 1741 |
| Number [Participants] |
3
0.2%
|
2
0.1%
|
2
0.1%
|
1
0.1%
|
| Title | Number of Participants With Worsening Vertebral Fractures Through Month 60 |
|---|---|
| Description | A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline. |
| Time Frame | Baseline through Month 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) |
|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1724 | 1741 | 1686 |
| Number [Participants] |
4
0.2%
|
1
0.1%
|
2
0.1%
|
| Title | Number of Participants With Worsening Vertebral Fractures Through Month 84 |
|---|---|
| Description | A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline. |
| Time Frame | Baseline through Month 84 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT population of SP1 population included all randomized participants who took at least 1 dose of test article and who had a vertebral radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. |
| Arm/Group Title | Placebo (Core+SE I+SE II) | Bazedoxifene 20 mg (SE II) |
|---|---|---|
| Arm/Group Description | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1741 | 3410 |
| Number [Participants] |
1
0.1%
|
7
0.4%
|
| Title | Percentage of Participants With Non-vertebral Fractures Through Month 36 |
|---|---|
| Description | Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized. |
| Time Frame | Baseline through Month 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1886 | 1872 | 1849 | 1885 |
| Osteoporosis-Related |
5.68
0.3%
|
5.61
0.3%
|
5.87
0.3%
|
6.26
0.3%
|
| Hip |
0.55
0%
|
0.34
0%
|
0.26
0%
|
0.31
0%
|
| Wrist |
2.28
0.1%
|
1.83
0.1%
|
2.51
0.1%
|
1.64
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Osteoporosis-Related: P value was calculated using Log-Rank test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.46 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Osteoporosis-Related: P value was calculated using Log-Rank test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.90 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Osteoporosis-Related: P value was calculated using Log-Rank test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.93 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Osteoporosis-Related: P value was calculated using Log-Rank test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.84 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Osteoporosis-Related: P value was calculated using Log-Rank test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.39 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Osteoporosis-Related: P value was calculated using Log-Rank test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.52 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Hip: P value was calculated using Log-Rank test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.28 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Hip: P value was calculated using Log-Rank test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.31 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Hip: P value was calculated using Log-Rank test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.17 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Hip: P value was calculated using Log-Rank test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.72 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Hip: P value was calculated using Log-Rank test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.97 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Hip: P value was calculated using Log-Rank test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.76 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Wrist: P value was calculated using Log-Rank test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.29 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Wrist: P value was calculated using Log-Rank test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.43 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Wrist: P value was calculated using Log-Rank test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.59 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Wrist: P value was calculated using Log-Rank test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.19 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Wrist: P value was calculated using Log-Rank test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.80 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Wrist: P value was calculated using Log-Rank test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.11 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Percentage of Participants With Non-vertebral Fractures Through Month 60 |
|---|---|
| Description | Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized. |
| Time Frame | Baseline through Month 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) |
|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1886 | 1872 | 1885 |
| Osteoporosis-Related |
9.47
0.5%
|
9.03
0.5%
|
7.59
0.4%
|
| Hip |
0.75
0%
|
0.65
0%
|
0.53
0%
|
| Wrist |
3.30
0.2%
|
2.79
0.1%
|
2.60
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.968 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.012 | |
| Confidence Interval |
(2-Sided) 95% 0.790 to 1.296 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 40/20 mg [SE I] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.211 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.846 | |
| Confidence Interval |
(2-Sided) 95% 0.652 to 1.097 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Bazedoxifene 40/20 mg [SE I]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.191 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.200 | |
| Confidence Interval |
(2-Sided) 95% 0.925 to 1.556 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.493 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.406 | |
| Confidence Interval |
(2-Sided) 95% 0.566 to 3.497 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 40/20 mg [SE I] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.820 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.872 | |
| Confidence Interval |
(2-Sided) 95% 0.316 to 2.405 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Bazedoxifene 40/20 mg [SE I]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.371 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.612 | |
| Confidence Interval |
(2-Sided) 95% 0.624 to 4.161 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.423 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.202 | |
| Confidence Interval |
(2-Sided) 95% 0.776 to 1.861 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 40/20 mg [SE I] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.799 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.936 | |
| Confidence Interval |
(2-Sided) 95% 0.587 to 1.491 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Bazedoxifene 40/20 mg [SE I]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.298 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.280 | |
| Confidence Interval |
(2-Sided) 95% 0.818 to 2.002 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants With Non-vertebral Fractures Through Month 84 |
|---|---|
| Description | Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized. |
| Time Frame | Baseline through Month 84 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT population of SP1 population:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. |
| Arm/Group Title | Placebo (Core+SE I+SE II) | Bazedoxifene 20 mg (SE II) |
|---|---|---|
| Arm/Group Description | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1885 | 3758 |
| Osteoporosis-Related |
10.77
0.6%
|
11.20
0.6%
|
| Hip |
1.34
0.1%
|
0.74
0%
|
| Wrist |
3.62
0.2%
|
4.61
0.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg [SE II] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.73 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.96 | |
| Confidence Interval |
(2-Sided) 95% 0.78 to 1.19 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg [SE II] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.71 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.87 | |
| Confidence Interval |
(2-Sided) 95% 0.41 to 1.83 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg [SE II] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.45 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.15 | |
| Confidence Interval |
(2-Sided) 95% 0.80 to 1.66 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Height at Month 36 |
|---|---|
| Description | Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded). |
| Time Frame | Baseline, Month 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. N (number of participants analyzed)=participants evaluable for this measure. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1236 | 1210 | 1231 | 1254 |
| Least Squares Mean (Standard Error) [millimeter (mm)] |
-3.7
(0.31)
|
-3.9
(0.31)
|
-4.5
(0.31)
|
-3.3
(0.31)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.31 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.039 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.13 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.12 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Title | Change From Baseline in Height at Month 60 |
|---|---|
| Description | Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded). |
| Time Frame | Baseline, Month 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. N (number of participants analyzed)=participants evaluable for this measure. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) |
|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 746 | 752 | 743 |
| Least Squares Mean (Standard Error) [mm] |
-0.50
(0.06)
|
-0.41
(0.06)
|
-0.41
(0.06)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.12 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.94 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Title | Change From Baseline in Height at Month 84 |
|---|---|
| Description | Height (cm) was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded). |
| Time Frame | Baseline, Month 84 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT population of SP1 population:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants evaluable for this measure. |
| Arm/Group Title | Placebo (Core+SE I+SE II) | Bazedoxifene 20 mg (SE II) |
|---|---|---|
| Arm/Group Description | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 407 | 736 |
| Mean (Standard Deviation) [mm] |
-0.68
(0.10)
|
-0.73
(0.08)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.26 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Title | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 |
|---|---|
| Description | BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher. |
| Time Frame | Baseline, Months 6, 12, 18, 24, 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article; had baseline BMD and at least one valid BMD while on therapy. N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1693 | 1663 | 1662 | 1711 |
| Lu Sp:Change at Month 6 (n=1693,1663,1662,1711) |
1.53
(0.09)
|
1.56
(0.09)
|
1.79
(0.09)
|
0.51
(0.09)
|
| Tl Hp:Change at Month 6 (n=1684,1653,1659,1699) |
0.75
(0.07)
|
0.85
(0.07)
|
1.07
(0.07)
|
0.24
(0.06)
|
| Fe Ne:Change at Month 6 (n=1687,1658,1662,1703) |
0.60
(0.09)
|
0.62
(0.09)
|
0.52
(0.09)
|
-0.05
(0.09)
|
| Fe Tr:Change at Month 6 (n=1687,1658,1662,1703) |
1.17
(0.10)
|
1.24
(0.10)
|
1.49
(0.10)
|
0.33
(0.10)
|
| Lu Sp:Change at Month 12 (n=1587,1541,1546,1599) |
2.06
(0.10)
|
2.13
(0.10)
|
2.50
(0.10)
|
0.61
(0.10)
|
| Tl Hp:Change at Month 12 (n=1578,1532,1532,1586) |
1.07
(0.07)
|
1.24
(0.08)
|
1.50
(0.08)
|
0.28
(0.07)
|
| Fe Ne:Change at Month 12 (n=1581,1537,1536,1591) |
0.92
(0.09)
|
1.10
(0.10)
|
1.27
(0.10)
|
0.08
(0.09)
|
| Fe Tr:Change at Month 12 (n=1581,1537,1536,1591) |
1.71
(0.11)
|
1.84
(0.11)
|
2.14
(0.11)
|
0.63
(0.11)
|
| Lu Sp:Change at Month 18 (n=1498,1444,1474,1487) |
2.00
(0.11)
|
2.24
(0.11)
|
2.58
(0.11)
|
0.52
(0.11)
|
| Tl Hp:Change at Month 18 (n=1486,1434,1459,1480) |
0.93
(0.08)
|
1.13
(0.08)
|
1.47
(0.08)
|
-0.07
(0.08)
|
| Fe Ne:Change at Month 18 (n=1489,1437,1463,1484) |
0.80
(0.10)
|
1.09
(0.10)
|
1.21
(0.10)
|
-0.24
(0.10)
|
| Fe Tr:Change at Month 18 (n=1489,1437,1463,1484) |
1.54
(0.12)
|
1.64
(0.12)
|
2.18
(0.12)
|
0.14
(0.12)
|
| Lu Sp:Change at Month 24 (n=1400,1347,1387,1398) |
1.99
(0.11)
|
2.12
(0.11)
|
2.74
(0.11)
|
0.47
(0.11)
|
| Tl Hp:Change at Month 24 (n=1394,1333,1379,1382) |
0.82
(0.09)
|
1.01
(0.09)
|
1.37
(0.09)
|
-0.35
(0.09)
|
| Fe Ne:Change at Month 24 (n=1398,1335,1381,1386) |
0.80
(0.10)
|
1.05
(0.11)
|
1.37
(0.10)
|
-0.58
(0.10)
|
| Fe Tr:Change at Month 24 (n=1398,1335,1381,1386) |
1.51
(0.12)
|
1.57
(0.13)
|
2.18
(0.13)
|
0.01
(0.13)
|
| Lu Sp:Change at Month 36 (n=1022,1029,1050,1054) |
2.21
(0.16)
|
2.38
(0.16)
|
2.96
(0.16)
|
0.88
(0.16)
|
| Tl Hp:Change at Month 36 (n=1019,1016,1044,1050) |
0.27
(0.12)
|
0.50
(0.12)
|
0.90
(0.12)
|
-0.83
(0.12)
|
| Fe Ne:Change at Month 36 (n=1020,1018,1046,1051) |
0.28
(0.15)
|
0.67
(0.15)
|
0.80
(0.15)
|
-1.30
(0.15)
|
| Fe Tr:Change at Month 36 (n=1020,1018,1046,1051) |
0.89
(0.17)
|
0.90
(0.17)
|
1.62
(0.17)
|
-0.50
(0.17)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in lumbar spine BMD: P value was calculated using Analysis of covariance (ANCOVA). | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.018 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.036 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.019 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 26
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 27
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 28
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 29
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 30
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 31
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 32
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 33
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 34
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 35
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 36
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 37
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 38
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 39
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 40
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 41
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.008 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 42
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 43
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 44
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 45
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.006 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 46
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 47
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 48
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 49
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 50
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 51
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 52
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 53
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 54
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 55
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 56
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.47 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 57
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 58
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 59
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 60
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.004 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 61
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 62
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 63
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 64
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 65
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 66
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.39 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 67
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.17 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 68
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.34 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 69
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.016 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 70
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.47 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 71
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 72
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 73
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 74
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 75
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 76
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 77
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 78
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 79
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 80
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 81
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.01 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 82
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 83
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 84
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 85
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 86
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 87
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 88
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 89
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 90
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 91
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.048 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 92
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.038 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 93
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 94
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 95
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 96
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 97
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 98
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 99
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 100
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Title | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 |
|---|---|
| Description | BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher. |
| Time Frame | Baseline, Month 48, 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT population of SP1 population:randomized participants who took at least 1 dose of test article; had baseline BMD and at least one valid BMD while on therapy. N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) |
|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 886 | 876 | 886 |
| Lu Sp:Change at Month 48 (n=886,876,886) |
1.92
(0.22)
|
0.84
(0.22)
|
2.02
(0.22)
|
| Tl Hp:Change at Month 48 (n=877,865,868) |
-0.17
(0.18)
|
-1.05
(0.18)
|
0.11
(0.18)
|
| Fe Ne:Change at Month 48 (n=879,866,870) |
0.02
(0.20)
|
-1.30
(0.20)
|
0.45
(0.20)
|
| Fe Tr:Change at Month 48 (n=879,734,870) |
0.18
(0.24)
|
-0.81
(0.25)
|
0.45
(0.25)
|
| Lu Sp:Change at Month 60 (n=742,747,746) |
2.16
(0.26)
|
1.46
(0.26)
|
2.08
(0.26)
|
| Tl Hp:Change at Month 60 (n=738,733,736) |
-0.48
(0.21)
|
-1.49
(0.21)
|
-0.29
(0.21)
|
| Fe Ne:Change at Month 60 (n=740,734,737) |
-0.18
(0.25)
|
-1.72
(0.25)
|
0.09
(0.25)
|
| Fe Tr:Change at Month 60 (n= 740,734,737) |
-0.13
(0.29)
|
-1.19
(0.29)
|
-0.00
(0.29)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 48 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 60 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.010 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 48 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 60 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.023 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 48 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 60 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 48 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 60 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 48 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 60 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 48 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 60 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 48 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 60 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 48 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 60 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Title | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84 |
|---|---|
| Description | BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher. |
| Time Frame | Baseline, Month 72, 84 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified ITT(mITT) population of SP1 population:randomized participants who took at least 1 dose of test article;had baseline BMD and at least one valid BMD while on therapy. N (number of participants analyzed)=participants evaluable.n=participants with specified baseline fracture status. |
| Arm/Group Title | Placebo (Core+SE I+SE II) | Bazedoxifene 20 mg (SE II) |
|---|---|---|
| Arm/Group Description | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 457 | 888 |
| Lu Sp:Change at Month 72 (n=457,888) |
1.80
(0.40)
|
2.24
(0.31)
|
| Tl Hp:Change at Month 72 (n=448,871) |
-1.96
(0.33)
|
-0.85
(0.25)
|
| Fe Ne:Change at Month 72 (n=448,871) |
-2.12
(0.39)
|
-0.60
(0.30)
|
| Fe Tr:Change at Month 72 (n=448,871) |
-1.43
(0.44)
|
-0.31
(0.34)
|
| Lu Sp:Change at Month 84 (n=417,800) |
2.19
(0.49)
|
2.95
(0.39)
|
| Tl Hp:Change at Month 84 (n=405,787) |
-2.53
(0.38)
|
-1.15
(0.30)
|
| Fe Ne:Change at Month 84 (n=405,787) |
-2.35
(0.43)
|
-0.80
(0.35)
|
| Fe Tr:Change at Month 84 (n=405,787) |
-2.72
(0.47)
|
-1.41
(0.38)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 72 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.34 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 84 in lumbar spine BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.15 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 72 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 84 in total hip BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 72 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 84 in femoral neck BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 72 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 84 in femoral trochanter BMD: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Title | Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12 |
|---|---|
| Description | Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels. |
| Time Frame | Baseline, Months 3, 6, 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1739 | 1708 | 1702 | 1746 |
| Change at Month 3 (n=1739,1708,1702,1746) |
-23.48
|
-25.28
|
-26.18
|
-11.37
|
| Change at Month 6 (n=1655,1634,1633,1681) |
-32.75
|
-35.20
|
-35.96
|
-17.82
|
| Change at Month 12 (n=1565,1522,1529,1573) |
-37.49
|
-39.15
|
-41.44
|
-21.00
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.93 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.30 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
| Title | Percent Change From Baseline in Osteocalcin at Months 36 and 60 |
|---|---|
| Description | Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels. |
| Time Frame | Baseline, Months 36, 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT of SP1 population included all randomized participants who took at least 1 dose of test article.'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) |
|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 178 | 168 | 181 |
| Change at Month 36 (n=178,168,181) |
-23.91
|
-12.73
|
-26.99
|
| Change at Month 60 (n=127, 127, 132) |
-25.21
|
-17.21
|
-30.41
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 36 in osteocalcin: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 60 in osteocalcin: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 36 in osteocalcin: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 60 in osteocalcin: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
| Title | Percent Change From Baseline in Osteocalcin at Months 72 and 84 |
|---|---|
| Description | Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels. |
| Time Frame | Baseline, Months 72, 84 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT of SP1 population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure. |
| Arm/Group Title | Placebo (Core+SE I+SE II) | Bazedoxifene 20 mg (SE II) |
|---|---|---|
| Arm/Group Description | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 97 | 170 |
| Change at Month 72 (n=97,170) |
-26.72
|
-33.76
|
| Change at Month 84 (n=84,147) |
-29.50
|
-32.25
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 72 in osteocalcin: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.037 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 84 in osteocalcin: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.16 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
| Title | Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12 |
|---|---|
| Description | C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels. |
| Time Frame | Baseline, Months 3, 6, 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1739 | 1708 | 1703 | 1746 |
| Change at Month 3 (n=1739,1708,1703,1746) |
-42.12
|
-45.11
|
-45.48
|
-26.17
|
| Change at Month 6 (n=1655,1634,1634,1681) |
-46.93
|
-50.00
|
-52.55
|
-27.94
|
| Change at Month 12 (n=1565,1522,1530,1573) |
-45.64
|
-48.77
|
-54.55
|
-27.31
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.40 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.004 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
| Title | Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60 |
|---|---|
| Description | C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels. |
| Time Frame | Baseline, Months 36, 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT of SP1 population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) |
|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 178 | 180 | 168 |
| Change at Month 36 (n=178,180,168) |
-30.54
|
-21.85
|
-32.26
|
| Change at Month 60 (n=127,131,126) |
-26.80
|
-10.40
|
-27.87
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 36 in C-telopeptide: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 60 in C-telopeptide: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 36 in C-telopeptide: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 60 in C-telopeptide: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.009 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
| Title | Percent Change From Baseline in C-telopeptide (CTx) at Months 72 and 84 |
|---|---|
| Description | C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels. |
| Time Frame | Baseline, Months 72, 84 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT of SP1 population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure. |
| Arm/Group Title | Placebo (Core+SE I+SE II) | Bazedoxifene 20 mg (SE II) |
|---|---|---|
| Arm/Group Description | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 97 | 170 |
| Change at Month 72 (n=97,170) |
-29.44
|
-37.41
|
| Change at Month 84 (n=84,147) |
-28.61
|
-28.17
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 72 in C-telopeptide: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.034 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 84 in C-telopeptide: P value was calculated using Ranked ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.77 |
| Comments | ||
| Method | Ranked ANCOVA | |
| Comments | ||
| Title | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 |
|---|---|
| Description | Lipid parameters evaluated included total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL), triglyceride (TG), high-density lipoprotein fraction 2 (HDL2) and high-density lipoprotein fraction 3 (HDL3). |
| Time Frame | Baseline, Months 6, 12, 24, 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1647 | 1623 | 1628 | 1674 |
| TC:Change at Month 6 (n=1646,1623,1628,1673) |
-3.89
|
-4.73
|
-5.50
|
0.00
|
| LDL:Change at Month 6 (n=1647,1623,1627,1674) |
-8.55
|
-10.18
|
-11.52
|
-1.17
|
| HDL:Change at Month 6 (n=1647,1619,1626,1671) |
1.43
|
1.06
|
0.00
|
0.00
|
| HDL2:Change at Month 6 (n=1643,1618,1623,1666) |
-13.89
|
-11.86
|
-14.75
|
-12.22
|
| HDL3:Change at Month 6 (n=1643,1619,1625,1668) |
9.38
|
8.60
|
8.70
|
6.90
|
| TG:Change at Month 6 (n=1646,1623,1628,1673) |
4.28
|
7.14
|
5.71
|
4.90
|
| TC:Change at Month 12 (n=1556,1515,1536,1578) |
-4.14
|
-3.66
|
-5.18
|
0.87
|
| LDL:Change at Month 12 (n=1559,1516,1534,1578) |
-7.79
|
-8.45
|
-10.28
|
0.66
|
| HDL:Change at Month 12 (n=1552,1513,1531,1576) |
1.14
|
0.66
|
0.58
|
-1.17
|
| HDL2:Change at Month 12 (n=1550,1510,1528,1570) |
-16.55
|
-16.33
|
-17.54
|
-14.29
|
| HDL3:Change at Month 12 (n=1551,1511,1531,1572) |
9.85
|
10.00
|
9.52
|
6.38
|
| TG:Change at Month 12 (n=1556,1515,1535,1578) |
5.95
|
8.14
|
6.25
|
7.99
|
| TC:Change at Month 24 (n=1378,1341,1377,1385) |
-4.17
|
-4.72
|
-5.68
|
0.38
|
| LDL:Change at Month 24 (n=1379,1341,1376,1384) |
-4.51
|
-5.94
|
-7.30
|
4.41
|
| HDL:Change at Month 24 (n=1377,1338,1374,1382) |
3.57
|
2.42
|
2.41
|
1.63
|
| HDL2:Change at Month 24 (n=1369,1336,1363,1377) |
-10.26
|
-11.94
|
-13.04
|
-10.61
|
| HDL3:Change at Month 24 (n=1370,1337,1365,1379) |
10.81
|
10.77
|
10.99
|
6.98
|
| TG:Change at Month 24 (n=1378,1341,1377,1385) |
4.23
|
8.09
|
5.17
|
6.19
|
| TC:Change at Month 36 (n=1220,1201,1225,1248) |
-3.75
|
-3.47
|
-5.04
|
0.34
|
| LDL:Change at Month 36 (n=1220,1201,1223,1247) |
-5.36
|
-6.63
|
-8.51
|
1.55
|
| HDL:Change at Month 36 (n=1216,1196,1219,1246) |
5.10
|
5.93
|
5.00
|
2.51
|
| HDL2:Change at Month 36 (n=1209,1191,1214,1236) |
-19.51
|
-17.07
|
-18.47
|
-18.66
|
| HDL3:Change at Month 36 (n=1210,1194,1218,1237) |
18.18
|
17.93
|
17.14
|
13.33
|
| TG:Change at Month 36 (n=1220,1201,1225,1248) |
8.48
|
13.59
|
12.21
|
12.11
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.009 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.055 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.004 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in LDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in LDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in LDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in LDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 6 in LDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 26
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 12 in LDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 27
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 24 in LDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 28
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 36 in LDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 29
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in LDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 30
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in LDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 31
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in LDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 32
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in LDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 33
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 6 in LDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.012 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 34
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 12 in LDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 35
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 24 in LDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.031 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 36
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 36 in LDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.008 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 37
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in LDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 38
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in LDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 39
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in LDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 40
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in LDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 41
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in HDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 42
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in HDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 43
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in HDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 44
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in HDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 45
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 6 in HDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.10 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 46
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 12 in HDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.89 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 47
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 24 in HDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.60 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 48
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 36 in HDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.82 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 49
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in HDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 50
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in HDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 51
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in HDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.012 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 52
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in HDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 53
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 6 in HDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.083 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 54
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 12 in HDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.96 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 55
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 24 in HDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.84 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 56
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 36 in HDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.15 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 57
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in HDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.13 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 58
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in HDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 59
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in HDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 60
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in HDL: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 61
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in HDL2: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.28 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 62
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in HDL2: P value was calculated using ANCOVA | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.10 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 63
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in HDL2: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.94 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 64
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in HDL2: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.46 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 65
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 6 in HDL2: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.63 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 66
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 12 in HDL2: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.70 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 67
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 24 in HDL2: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.58 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 68
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 36 in HDL2: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.29 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 69
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in HDL2: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.59 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 70
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in HDL2: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.036 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 71
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in HDL2: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.57 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 72
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in HDL2: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.49 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 73
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 6 in HDL2: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.038 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 74
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 12 in HDL2: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.93 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 75
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 24 in HDL2: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.96 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 76
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 36 in HDL2: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.72 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 77
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in HDL2: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.12 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 78
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in HDL2: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.043 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 79
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in HDL2: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.53 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 80
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in HDL2: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.75 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 81
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in HDL3: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 82
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in HDL3: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 83
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in HDL3: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 84
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in HDL3: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 85
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 6 in HDL3: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.46 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 86
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 12 in HDL3: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.64 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 87
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 24 in HDL3: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.47 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 88
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 36 in HDL3: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.75 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 89
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in HDL3: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 90
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in HDL3: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 91
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in HDL3: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 92
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in HDL3: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 93
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 6 in HDL3: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.81 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 94
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 12 in HDL3: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.98 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 95
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 24 in HDL3: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.87 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 96
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 36 in HDL3: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.40 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 97
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in HDL3: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 98
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in HDL3: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 99
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in HDL3: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 100
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in HDL3: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 101
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.85 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 102
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.26 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 103
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.33 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 104
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.22 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 105
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.86 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 106
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.65 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 107
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.00 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 108
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.44 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 109
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.058 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 110
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.55 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 111
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.34 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 112
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.96 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 113
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.058 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 114
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.031 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 115
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.054 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 116
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.62 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 117
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.99 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 118
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.11 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 119
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.33 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 120
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.65 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Title | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP |
|---|---|
| Description | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Percentage of following indices (volume,surface,porosity) was calculated:Bone Volume(BV), Osteoid Volume(OV), Osteoid Surface(OS), Osteoclast Surface(OcS), Osteoblast Surface(ObS), Mineralizing surface(MS), Eroded Surface(ES), Osteoid Mineralizing surface(OMS), Cortical porosity(CP). |
| Time Frame | Month 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 28 | 29 | 32 | 32 |
| BV (n=25,27,28,30) |
17.078
(1.140)
|
19.155
(1.097)
|
16.650
(1.077)
|
17.144
(1.041)
|
| OV (n=25,27,28,30) |
1.513
(0.244)
|
1.644
(0.234)
|
1.290
(0.230)
|
1.605
(0.222)
|
| OS (n=25,27,28,30) |
12.516
(1.795)
|
14.196
(1.728)
|
12.442
(1.697)
|
12.934
(1.639)
|
| OcS (n=25,27,28,30) |
0.276
(0.045)
|
0.334
(0.043)
|
0.215
(0.043)
|
0.242
(0.041)
|
| ObS (n=25,27,28,30) |
4.235
(0.623)
|
4.225
(0.600)
|
2.772
(0.589)
|
3.672
(0.569)
|
| MS (n=25,27,28,30) |
5.962
(0.852)
|
5.960
(0.820)
|
3.926
(0.805)
|
5.705
(0.778)
|
| ES (n=25,27,28,30) |
1.610
(0.196)
|
1.855
(0.189)
|
1.891
(0.185)
|
1.299
(0.179)
|
| OMS (n=28,29,32,32) |
49.629
(5.442)
|
49.145
(5.347)
|
37.856
(5.091)
|
51.503
(5.091)
|
| CP (n=25,27,27,29) |
4.484
(0.397)
|
4.130
(0.382)
|
4.319
(0.382)
|
4.334
(0.369)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | BV: P value was calculated using Analysis of Variance (ANOVA). | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.97 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | BV: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.19 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | BV: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.74 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | BV: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.79 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | BV: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.11 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | OV: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.78 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | OV: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.90 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | OV: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.33 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | OV: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.51 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | OV: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.28 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | OS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.86 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | OS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.60 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | OS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.84 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | OS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.98 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | OS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.47 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | OcS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.59 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | OcS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.13 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | OcS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.65 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | OcS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.33 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | OcS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.053 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ObS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.51 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ObS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.50 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ObS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.27 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ObS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.091 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ObS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.087 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 26
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | MS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.82 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 27
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | MS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.82 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 28
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | MS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.12 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 29
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | MS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.085 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 30
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | MS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.080 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 31
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ES: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.24 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 32
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ES: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.035 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 33
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ES: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.024 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 34
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ES: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.30 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 35
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ES: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.89 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 36
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | OMS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.80 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 37
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | OMS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.75 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 38
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | OMS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.060 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 39
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | OMS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.12 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 40
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | OMS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.13 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 41
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | CP: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.78 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 42
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | CP: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.70 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 43
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | CP: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.98 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 44
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | CP: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.76 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 45
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | CP: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.73 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP |
|---|---|
| Description | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Percentage of following indices (volume,surface,porosity) was calculated:Bone Volume(BV), Osteoid Volume(OV), Osteoid Surface(OS), Osteoclast Surface(OcS), Osteoblast Surface(ObS), Mineralizing surface(MS), Eroded Surface(ES), Osteoid Mineralizing surface(OMS), Cortical porosity(CP). |
| Time Frame | Month 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) |
|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 3 | 5 | 1 |
| BV (n=2,4,1) |
20.315
(4.882)
|
17.818
(3.452)
|
21.590
(6.905)
|
| OV (n=2,4,1) |
2.550
(0.258)
|
0.893
(0.183)
|
2.790
(0.365)
|
| OS (n=2,4,1) |
20.270
(3.091)
|
9.772
(2.186)
|
23.870
(4.372)
|
| OcS (n=2,4,1) |
0.445
(0.137)
|
0.173
(0.097)
|
0.310
(0.193)
|
| ObS (n=2,4,1) |
7.170
(2.100)
|
2.430
(1.485)
|
7.260
(2.970)
|
| MS (n=2,4,1) |
6.910
(1.614)
|
2.920
(1.142)
|
9.780
(2.283)
|
| ES (n=2,4,1) |
1.225
(0.226)
|
0.542
(0.160)
|
0.990
(0.319)
|
| OMS (n=3,5,1) |
57.300
(21.483)
|
43.060
(16.640)
|
40.900
(37.209)
|
| CP (n=0,0,0) |
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | BV: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.70 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | BV: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.65 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | OV: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.006 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | OV: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.010 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | OS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.050 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | OS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.045 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | OcS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.18 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | OcS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.56 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | ObS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.14 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ObS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.22 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | MS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.11 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | MS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.055 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | ES: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.069 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ES: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.28 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | OMS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.62 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | OMS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.96 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh |
|---|---|
| Description | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Wall Thickness (WTh), Osteoid Thickness (OTh), Trabecular Thickness (TbTh), Trabecular Separation (TbSp) and Cortical thickness (CTh). Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest. |
| Time Frame | Month 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 25 | 27 | 28 | 30 |
| WTh (n=25,27,28,30) |
31.348
(0.541)
|
31.689
(0.521)
|
31.089
(0.512)
|
30.447
(0.494)
|
| OTh (n=25,27,28,30) |
6.180
(0.221)
|
6.085
(0.212)
|
5.554
(0.209)
|
5.660
(0.202)
|
| TbTh (n=25,27,28,30) |
140.440
(7.128)
|
146.296
(6.859)
|
139.143
(6.735)
|
131.333
(6.507)
|
| TbSp (n=25,27,28,30) |
865.040
(42.634)
|
770.148
(41.024)
|
880.571
(40.285)
|
787.900
(38.919)
|
| CTh (n=25,27,27,30) |
891.480
(68.949)
|
694.370
(66.346)
|
781.593
(66.346)
|
761.467
(62.941)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | WTh: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.22 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | WTh: p-value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.087 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | WTh: p-value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.37 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | WTh: p-value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.73 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | WTh: p-value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.41 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | OTh: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.085 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | OTh: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.15 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | OTh: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.71 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | OTh: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.042 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | OTh: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.077 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | TbTh: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.35 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | TbTh: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.12 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | TbTh: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.41 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | TbTh: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.90 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | TbTh: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.46 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | TbSp: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.18 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | TbSp: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.75 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | TbSp: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.10 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | TbSp: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.79 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | TbSp: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.057 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | CTh: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.17 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | CTh: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.46 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | CTh: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.83 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | CTh: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.25 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | CTh: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.35 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh |
|---|---|
| Description | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: WTh, OTh, TbTh, TbSp and CTh. Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest. |
| Time Frame | Month 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) |
|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 2 | 4 | 1 |
| WTh (n=2,4,1) |
34.250
(0.833)
|
30.300
(0.589)
|
28.700
(1.177)
|
| OTh (n=2,4,1) |
7.450
(0.571)
|
5.500
(0.404)
|
6.400
(0.807)
|
| TbTh (n=2,4,1) |
154.500
(29.636)
|
153.000
(20.956)
|
139.000
(41.912)
|
| TbSp (n=2,4,1) |
748.000
(161.893)
|
920.750
(114.476)
|
628.000
(228.951)
|
| CTh (n=0,0,0) |
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | WTh: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.018 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | WTh: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.29 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | OTh: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.049 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | OTh: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.37 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | TbTh: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.97 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | TbTh: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.78 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | TbSp: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.43 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | TbSp: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.32 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Bone Histomorphometric Indices at Month 36: Total Surface (Goldner Slide) [TSG] |
|---|---|
| Description | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Total Surface (Goldner Slide) [TSG]. All specimens were demineralized and subjected to staining procedures (Goldner's staining). Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm^2 and expressed as percent (%) of the total surface. |
| Time Frame | Month 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 28 | 29 | 32 | 32 |
| Least Squares Mean (Standard Error) [millimeter (mm)] |
95.111
(8.429)
|
110.897
(8.283)
|
94.353
(7.885)
|
105.912
(7.885)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.35 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.66 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.30 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.95 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.15 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Bone Histomorphometric Indices at Month 60: TSG |
|---|---|
| Description | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Total Surface (Goldner Slide) [TSG]. All specimens were demineralized and subjected to staining procedures (Goldner's staining). Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm^2 and expressed as percent (%) of the total surface. |
| Time Frame | Month 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) |
|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 3 | 5 | 1 |
| Least Squares Mean (Standard Error) [mm] |
75.333
(30.542)
|
75.560
(23.658)
|
128.500
(52.900)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.00 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.40 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Bone Histomorphometric Indices at Month 36: TtAr |
|---|---|
| Description | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated variable: Tissue Area (TtAr). Tissue area comprised of the porous calcified substance from which bones were made. |
| Time Frame | Month 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 28 | 29 | 32 | 32 |
| Least Squares Mean (Standard Error) [Square millimeter (mm^2)] |
39.904
(3.066)
|
42.334
(3.013)
|
39.497
(2.868)
|
41.459
(2.868)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.71 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.83 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.63 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.92 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.50 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Bone Histomorphometric Indices at Month 60: TtAr |
|---|---|
| Description | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated variable: Tissue Area (TtAr). Tissue area comprised of the porous calcified substance from which bones were made. |
| Time Frame | Month 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) |
|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 3 | 5 | 1 |
| Least Squares Mean (Standard Error) [mm^2] |
28.767
(12.993)
|
34.600
(10.064)
|
41.200
(22.504)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.73 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.80 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Bone Histomorphometric Indices at Month 36: BFP, RP and RmP |
|---|---|
| Description | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Bone Formation Period (BFP), Resorption Period (RP), Remodeling Period (RmP). |
| Time Frame | Month 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 24 | 27 | 24 | 27 |
| BFP (n=24,27,24,27) |
0.463
(0.080)
|
0.441
(0.076)
|
0.751
(0.080)
|
0.436
(0.076)
|
| RP (n=24,27,24,27) |
0.080
(0.029)
|
0.066
(0.027)
|
0.125
(0.029)
|
0.096
(0.027)
|
| RmP (n=24,27,24,27) |
0.543
(0.095)
|
0.508
(0.090)
|
0.876
(0.095)
|
0.531
(0.090)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | BFP: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.81 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | BFP: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.96 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | BFP: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | BFP: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.013 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | BFP: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.006 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | RP: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.70 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | RP: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.44 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | RP: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.47 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | RP: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.28 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | RP: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.14 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | RmP: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.93 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | RmP: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.85 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | RmP: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.010 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | RmP: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.015 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | RmP: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.006 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Bone Histomorphometric Indices at Month 60: BFP, RP and RmP |
|---|---|
| Description | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Bone Formation Period (BFP), Resorption Period (RP), Remodeling Period (RmP). |
| Time Frame | Month 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) |
|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 2 | 4 | 1 |
| BFP (n=2,4,1) |
0.545
(0.391)
|
0.820
(0.277)
|
0.390
(0.553)
|
| RP (n=2,4,1) |
0.035
(0.011)
|
0.035
(0.008)
|
0.020
(0.015)
|
| RmP (n=2,4,1) |
0.580
(0.403)
|
0.860
(0.285)
|
0.410
(0.569)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | BFP: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.60 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | BFP: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.53 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | RP: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.00 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | RP: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.43 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | RmP: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.60 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | RmP: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.52 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Bone Histomorphometric Indices at Month 36: SuD |
|---|---|
| Description | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Surface Density (SuD). |
| Time Frame | Month 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 25 | 27 | 28 | 30 |
| Least Squares Mean (Standard Error) [square millimeter per cubic millimeter] |
2.405
(0.109)
|
2.632
(0.105)
|
2.424
(0.103)
|
2.587
(0.100)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.22 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.76 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.26 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.90 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.16 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Bone Histomorphometric Indices at Month 60: SuD |
|---|---|
| Description | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Surface Density (SuD). |
| Time Frame | Month 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) |
|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 2 | 4 | 1 |
| Least Squares Mean (Standard Error) [square millimeter per cubic millimeter] |
2.625
(0.338)
|
2.248
(0.239)
|
3.120
(0.479)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.41 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.18 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Bone Histomorphometric Indices at Month 36: BFRTS |
|---|---|
| Description | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS). BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR). |
| Time Frame | Month 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 24 | 27 | 24 | 27 |
| Least Squares Mean (Standard Error) [cubic millimetre/square millimetre/year] |
0.013
(0.002)
|
0.012
(0.002)
|
0.009
(0.002)
|
0.012
(0.002)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.68 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.97 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.18 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.088 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.17 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Bone Histomorphometric Indices at Month 60: BFRTS |
|---|---|
| Description | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS). BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR). |
| Time Frame | Month 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) |
|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 2 | 4 | 1 |
| Least Squares Mean (Standard Error) [cubic millimetre/square millimetre/year] |
0.013
(0.003)
|
0.006
(0.002)
|
0.018
(0.005)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.25 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.10 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Bone Histomorphometric Indices at Month 36: ACF |
|---|---|
| Description | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF). The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP. The number of times per year that this spot begins the FP is the activation frequency (ACF). |
| Time Frame | Month 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 24 | 27 | 24 | 27 |
| Least Squares Mean (Standard Error) [Activation of bone formation/year] |
0.421
(0.058)
|
0.385
(0.054)
|
0.290
(0.058)
|
0.410
(0.054)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.90 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.74 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.13 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.11 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.24 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Bone Histomorphometric Indices at Month 60: ACF |
|---|---|
| Description | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF). The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP. The number of times per year that this spot begins the FP is the activation frequency (ACF). |
| Time Frame | Month 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) |
|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 2 | 4 | 1 |
| Least Squares Mean (Standard Error) [Activation of bone formation/year] |
0.375
(0.106)
|
0.198
(0.075)
|
0.610
(0.151)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.25 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.070 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Bone Histomorphometric Indices at Month 36: Mlt |
|---|---|
| Description | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineralization Lag Time (Mlt). Mineralization lag time was the lag between the time osteoid was formed and the mineral was added. |
| Time Frame | Month 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 24 | 27 | 24 | 27 |
| Least Squares Mean (Standard Error) [days] |
31.650
(5.141)
|
30.337
(4.847)
|
48.383
(5.141)
|
29.533
(4.847)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.77 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.91 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.009 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.023 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.012 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Bone Histomorphometric Indices at Month 60: Mlt |
|---|---|
| Description | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineralization Lag Time (Mlt). Mineralization lag time was the lag between the time osteoid was formed and the mineral was added. |
| Time Frame | Month 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) |
|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 2 | 4 | 1 |
| Least Squares Mean (Standard Error) [days] |
43.450
(21.817)
|
51.100
(15.427)
|
31.900
(30.855)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.79 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.61 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Bone Histomorphometric Indices at Month 36: MAR |
|---|---|
| Description | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineral Apposition Rate (MAR). MAR is the area of new bone formed during the label interval. |
| Time Frame | Month 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 24 | 27 | 24 | 27 |
| Least Squares Mean (Standard Error) [mcm/days (mcm/d)] |
0.578
(0.020)
|
0.563
(0.019)
|
0.520
(0.020)
|
0.550
(0.019)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.30 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.62 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.28 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.041 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.12 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Bone Histomorphometric Indices at Month 60: MAR |
|---|---|
| Description | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineral Apposition Rate (MAR). MAR is the area of new bone formed during the label interval. |
| Time Frame | Month 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) |
|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 2 | 4 | 1 |
| Least Squares Mean (Standard Error) [mcm/d] |
0.525
(0.095)
|
0.573
(0.067)
|
0.490
(0.134)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.70 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.61 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Bone Histomorphometric Indices at Month 36: TbN |
|---|---|
| Description | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Trabecular Number (TbN). TbN= Ratio of bone volume to tissue volume divided by trabecular thickness. |
| Time Frame | Month 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 25 | 27 | 28 | 30 |
| Least Squares Mean (Standard Error) [ratio/millimeter (ratio/mm)] |
1.202
(0.055)
|
1.315
(0.053)
|
1.212
(0.052)
|
1.293
(0.050)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.22 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.76 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.26 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.89 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.17 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Bone Histomorphometric Indices at Month 60: TbN |
|---|---|
| Description | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Trabecular Number (TbN). TbN= Ratio of bone volume to tissue volume divided by trabecular thickness. |
| Time Frame | Month 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) |
|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 2 | 4 | 1 |
| Least Squares Mean (Standard Error) [ratio/mm] |
1.315
(0.168)
|
1.125
(0.119)
|
1.560
(0.238)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.41 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.18 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Bone Histomorphometric Indices at Month 36: BFRBV |
|---|---|
| Description | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV). BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR). |
| Time Frame | Month 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 24 | 27 | 24 | 27 |
| Least Squares Mean (Standard Error) [square millimetre/square millimetre/year] |
0.186
(0.024)
|
0.171
(0.022)
|
0.122
(0.024)
|
0.187
(0.022)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.97 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.61 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.050 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.061 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.14 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Bone Histomorphometric Indices at Month 60: BFRBV |
|---|---|
| Description | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV). BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR). |
| Time Frame | Month 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) |
|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 2 | 4 | 1 |
| Least Squares Mean (Standard Error) [square millimetre/square millimetre/year] |
0.167
(0.042)
|
0.075
(0.030)
|
0.253
(0.059)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Bazedoxifene 40 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.15 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.056 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Women's Health Questionnaire (WHQ) |
|---|---|
| Description | WHQ is a measure of mid-aged women's emotional and physical health. Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness. Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes). Domain subscale score was calculated as sum of domain items score divided by number of domain items. Total score was calculated as the sum of individual domain subscale score divided by number of domains. Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction. Baseline values at different time points were considered only for the participants who were evaluable at those time points. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants who were evaluable for this measure at the specified time point for each arm group. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1490 | 1435 | 1461 | 1503 |
| Baseline: Month 12 (n=1490,1435,1461,1503) |
0.342
(0.176)
|
0.348
(0.176)
|
0.341
(0.182)
|
0.343
(0.182)
|
| Baseline: Month 24 (n=1307,1271,1311,1318) |
0.339
(0.175)
|
0.343
(0.176)
|
0.338
(0.183)
|
0.343
(0.181)
|
| Baseline: Month 36 (n=1153,1138,1168,1179) |
0.333
(0.173)
|
0.341
(0.175)
|
0.341
(0.182)
|
0.339
(0.180)
|
| Title | Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36 |
|---|---|
| Description | WHQ is a measure of mid-aged women's emotional and physical health. Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness. Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes). Domain subscale score was calculated as sum of domain items score divided by number of domain items. Total score was calculated as the sum of individual domain subscale score divided by number of domains. Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction.Baseline values at different time points were considered only for the participants who were evaluable at those time points. |
| Time Frame | Baseline, Months 12, 24, 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants who were evaluable for this measure at the specified time point for each arm group. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1409 | 1435 | 1461 | 1503 |
| Change at Month 12 (n=1490,1435,1461,1503) |
0.000
(0.003)
|
0.001
(0.003)
|
0.001
(0.003)
|
-0.005
(0.003)
|
| Change at Month 24 (n=1307,1271,1311,1318) |
0.005
(0.004)
|
0.006
(0.004)
|
0.007
(0.004)
|
-0.002
(0.004)
|
| Change at Month 36 (n=1153,1138,1168,1179) |
0.011
(0.005)
|
-0.000
(0.005)
|
0.005
(0.005)
|
0.005
(0.005)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 12 in WHQ: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.20 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 12 in WHQ: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.12 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 12 in WHQ: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.17 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Change at Month 12 in WHQ: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.92 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Change at Month 12 in WHQ: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.86 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 24 in WHQ: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.18 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 24 in WHQ: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.12 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 24 in WHQ: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.096 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Change at Month 24 in WHQ: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.76 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Change at Month 24 in WHQ: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.93 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 36 in WHQ: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.36 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 36 in WHQ: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.34 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 36 in WHQ: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.98 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Change at Month 36 in WHQ: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.35 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Change at Month 36 in WHQ: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.35 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) |
|---|---|
| Description | QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. Baseline values at different time points were considered only for the participants who were evaluable at those time points. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants who were evaluable for this measure at the specified time point for each arm group. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1490 | 1438 | 1455 | 1495 |
| Baseline: Month 12 (n=1490,1438,1455,1495) |
24.57
(12.95)
|
24.50
(12.70)
|
23.98
(12.54)
|
24.31
(12.62)
|
| Baseline: Month 24 (n=1305,1276,1307,1312) |
24.33
(12.75)
|
24.24
(12.58)
|
23.80
(12.62)
|
24.29
(12.60)
|
| Baseline: Month 36 (n=1155,1136,1168,1176) |
23.87
(12.70)
|
24.12
(12.42)
|
23.88
(12.51)
|
23.97
(12.27)
|
| Title | Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36 |
|---|---|
| Description | QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. Baseline values at different time points were considered only for the participants who were evaluable at those time points. |
| Time Frame | Baseline, Months 12, 24, 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants who were evaluable for this measure at the specified time point for each arm group. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1490 | 1438 | 1455 | 1495 |
| Change at Month 12 (n=1490,1438,1455,1495) |
-0.24
(0.23)
|
-0.91
(0.24)
|
-0.49
(0.24)
|
-0.77
(0.23)
|
| Change at Month 24 (n=1305,1276,1307,1312) |
-0.00
(0.27)
|
0.02
(0.28)
|
0.29
(0.27)
|
-0.39
(0.27)
|
| Change at Month 36 (n=1155,1136,1168,1176) |
0.62
(0.30)
|
-0.11
(0.30)
|
0.26
(0.30)
|
-0.35
(0.30)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 12 in QUALEFFO: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.080 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Change at Month 12 in QUALEFFO: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.41 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 12 in QUALEFFO: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.65 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Change at Month 12 in QUALEFFO: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.18 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 12 in QUALEFFO: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.36 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 24 in QUALEFFO: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.27 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 24 in QUALEFFO: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.25 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 24 in QUALEFFO: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.053 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Change at Month 24 in QUALEFFO: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.40 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Change at Month 24 in QUALEFFO: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.45 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 36 in QUALEFFO: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.012 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 36 in QUALEFFO: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.54 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 36 in QUALEFFO: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.11 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Change at Month 36 in QUALEFFO: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.35 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Change at Month 36 in QUALEFFO: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.34 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) |
|---|---|
| Description | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants who were evaluable for this measure at the specified time point for each arm group. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1381 | 1346 | 1362 | 1407 |
| Baseline: Month 12 (n=1381,1346,1362,1407) |
79.20
(18.05)
|
80.89
(39.47)
|
82.23
(45.23)
|
80.95
(32.47)
|
| Baseline: Month 24 (n=1210,1200,1223,1247) |
79.11
(17.99)
|
80.73
(33.66)
|
82.86
(49.89)
|
80.79
(31.66)
|
| Baseline: Month 36 (n=1070,1065,1092,1120) |
79.78
(18.00)
|
81.43
(35.02)
|
83.50
(52.36)
|
81.07
(31.54)
|
| Title | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36 |
|---|---|
| Description | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points. |
| Time Frame | Baseline, Months 12, 24, 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants who were evaluable for this measure at the specified time point for each arm group. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1381 | 1346 | 1362 | 1407 |
| Change at Month 12 (n=1381,1346,1362,1407) |
1.59
(1.23)
|
0.12
(1.24)
|
-1.39
(1.23)
|
-0.37
(1.21)
|
| Change at Month 24 (n=1210,1200,1223,1247) |
0.45
(1.39)
|
-1.13
(1.40)
|
-1.63
(1.37)
|
-2.12
(1.37)
|
| Change at Month 36 (n=1070,1065,1092,1120) |
5.73
(1.74)
|
3.87
(1.74)
|
1.60
(1.71)
|
4.66
(1.70)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.21 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.058 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.76 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.34 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.51 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.14 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.57 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.78 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.24 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.78 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.62 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.72 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.16 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.059 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.30 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score |
|---|---|
| Description | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants who were evaluable for this measure at the specified time point for each arm group. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1425 | 1375 | 1393 | 1436 |
| Baseline: Month 12 (n=1425,1375,1393,1436) |
0.81
(0.20)
|
0.82
(0.20)
|
0.82
(0.19)
|
0.81
(0.21)
|
| Baseline: Month 24 (n=1243,1220,1240,1267) |
0.81
(0.20)
|
0.82
(0.19)
|
0.82
(0.19)
|
0.81
(0.21)
|
| Baseline: Month 36 (n=1095,1078,1111,1128) |
0.82
(0.20)
|
0.82
(0.18)
|
0.82
(0.19)
|
0.82
(0.20)
|
| Title | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36 |
|---|---|
| Description | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points. |
| Time Frame | Baseline, Months 12, 24, 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants who were evaluable for this measure at the specified time point for each arm group. |
| Arm/Group Title | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) |
|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily. | Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. |
| Measure Participants | 1425 | 1375 | 1393 | 1436 |
| Change at Month 12 (n=1425,1375,1393,1436) |
0.01
(0.01)
|
0.01
(0.01)
|
0.01
(0.01)
|
0.01
(0.01)
|
| Change at Month 24(n=1243,1220,1240,1267) |
0.00
(0.01)
|
-0.01
(0.01)
|
-0.01
(0.01)
|
0.01
(0.01)
|
| Change at Month 36 (n=1095,1078,1111,1128) |
-0.00
(0.01)
|
-0.01
(0.01)
|
-0.01
(0.01)
|
-0.00
(0.01)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 12 in EQ-5D: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.72 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 12 in EQ-5D: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.98 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 12 in EQ-5D: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.84 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Change at Month 12 in EQ-5D: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.88 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Change at Month 12 in EQ-5D: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.86 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 24 in EQ-5D: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.82 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 24 in EQ-5D: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.11 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 24 in EQ-5D: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.14 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Change at Month 24 in EQ-5D: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.22 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Change at Month 24 in EQ-5D: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.88 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 36 in EQ-5D: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.96 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 36 in EQ-5D: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.76 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Raloxifene 60 mg (Core), Placebo (Core+SE I+SE II) |
|---|---|---|
| Comments | Change at Month 36 in EQ-5D: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.92 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg (Core+SE I), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Change at Month 36 in EQ-5D: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.89 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 40 mg (Core), Raloxifene 60 mg (Core) |
|---|---|---|
| Comments | Change at Month 36 in EQ-5D: P value was calculated using ANOVA. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.83 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. | |||||||
| Arm/Group Title | Bazedoxifene 20 mg | Bazedoxifene 40/ 20 mg | Raloxifene 60 mg (Core Study) | Placebo | ||||
| Arm/Group Description | Bazedoxifene acetate 20 mg capsule orally once daily along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily in core study, study extension I and II. | Bazedoxifene acetate 40 mg capsule orally once daily in the core study, in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, and II along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Raloxifene 60 mg capsule orally once daily in the core study along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | Matching placebo capsule orally once daily along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily in the core study, study extension I and II. | ||||
All Cause Mortality |
||||||||
| Bazedoxifene 20 mg | Bazedoxifene 40/ 20 mg | Raloxifene 60 mg (Core Study) | Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Bazedoxifene 20 mg | Bazedoxifene 40/ 20 mg | Raloxifene 60 mg (Core Study) | Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 507/1886 (26.9%) | 468/1872 (25%) | 393/1849 (21.3%) | 479/1885 (25.4%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Acute myeloblastic leukemia | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Anemia | 0/1886 (0%) | 2/1872 (0.1%) | 2/1849 (0.1%) | 4/1885 (0.2%) | ||||
| Chronic lymphocytic leukemia | 2/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Ecchymosis | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Iron deficiency anemia | 1/1886 (0.1%) | 1/1872 (0.1%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Leukocytosis | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Leukopenia | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Lymphadenopathy | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Lymphocytosis | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 2/1885 (0.1%) | ||||
| Lymphoma | 1/1886 (0.1%) | 1/1872 (0.1%) | 2/1849 (0.1%) | 4/1885 (0.2%) | ||||
| Lymphoma like reaction | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Myeloma | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Myeloproliferative disorder | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Neutropenia | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Pancytopenia | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Petechiae | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Thrombocytopenia | 1/1886 (0.1%) | 0/1872 (0%) | 1/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Cardiac disorders | ||||||||
| Aneurysm | 0/1886 (0%) | 2/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Angina pectoris | 13/1886 (0.7%) | 6/1872 (0.3%) | 10/1849 (0.5%) | 9/1885 (0.5%) | ||||
| Aortic stenosis | 3/1886 (0.2%) | 4/1872 (0.2%) | 2/1849 (0.1%) | 2/1885 (0.1%) | ||||
| Arrhythmia | 4/1886 (0.2%) | 1/1872 (0.1%) | 2/1849 (0.1%) | 0/1885 (0%) | ||||
| Arterial anomaly | 1/1886 (0.1%) | 1/1872 (0.1%) | 0/1849 (0%) | 2/1885 (0.1%) | ||||
| Arterial thrombosis | 1/1886 (0.1%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Arteriosclerosis | 1/1886 (0.1%) | 2/1872 (0.1%) | 0/1849 (0%) | 2/1885 (0.1%) | ||||
| Atrial fibrillation | 9/1886 (0.5%) | 10/1872 (0.5%) | 6/1849 (0.3%) | 6/1885 (0.3%) | ||||
| Atrial flutter | 2/1886 (0.1%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| AV block | 1/1886 (0.1%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| AV block complete | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| AV block second degree | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Bradycardia | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 2/1885 (0.1%) | ||||
| Cardiac tamponade | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Cardiomegaly | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Cardiomyopathy | 0/1886 (0%) | 2/1872 (0.1%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Cardiovascular disorder | 1/1886 (0.1%) | 2/1872 (0.1%) | 1/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Carotid occlusion | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Carotid thrombosis | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Cerebral hemorrhage | 1/1886 (0.1%) | 1/1872 (0.1%) | 0/1849 (0%) | 2/1885 (0.1%) | ||||
| Cerebral infarct | 0/1886 (0%) | 4/1872 (0.2%) | 1/1849 (0.1%) | 2/1885 (0.1%) | ||||
| Cerebral ischemia | 6/1886 (0.3%) | 10/1872 (0.5%) | 6/1849 (0.3%) | 7/1885 (0.4%) | ||||
| Cerebral thrombosis | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Cerebrovascular accident | 14/1886 (0.7%) | 17/1872 (0.9%) | 10/1849 (0.5%) | 18/1885 (1%) | ||||
| Cerebrovascular disorder | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Congestive heart failure | 3/1886 (0.2%) | 4/1872 (0.2%) | 3/1849 (0.2%) | 2/1885 (0.1%) | ||||
| Coronary artery disorder | 9/1886 (0.5%) | 8/1872 (0.4%) | 5/1849 (0.3%) | 3/1885 (0.2%) | ||||
| Coronary occlusion | 1/1886 (0.1%) | 1/1872 (0.1%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Deep vein thrombosis | 8/1886 (0.4%) | 13/1872 (0.7%) | 10/1849 (0.5%) | 3/1885 (0.2%) | ||||
| Electrocardiogram abnormal | 0/1886 (0%) | 0/1872 (0%) | 2/1849 (0.1%) | 0/1885 (0%) | ||||
| Embolus lower extremity | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Extrasystoles | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Heart arrest | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 4/1885 (0.2%) | ||||
| Heart block | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Heart failure | 3/1886 (0.2%) | 5/1872 (0.3%) | 6/1849 (0.3%) | 1/1885 (0.1%) | ||||
| Hemorrhage | 0/1886 (0%) | 0/1872 (0%) | 2/1849 (0.1%) | 0/1885 (0%) | ||||
| Hypertension | 13/1886 (0.7%) | 8/1872 (0.4%) | 18/1849 (1%) | 17/1885 (0.9%) | ||||
| Hypertensive encephalopathy | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Hypotension | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Infarct | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Intracranial aneurysm | 0/1886 (0%) | 1/1872 (0.1%) | 2/1849 (0.1%) | 0/1885 (0%) | ||||
| Intracranial hemorrhage | 0/1886 (0%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Mesenteric occlusion | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Migraine | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Myocardial infarct | 9/1886 (0.5%) | 10/1872 (0.5%) | 8/1849 (0.4%) | 11/1885 (0.6%) | ||||
| Myocardial ischemia | 6/1886 (0.3%) | 1/1872 (0.1%) | 3/1849 (0.2%) | 1/1885 (0.1%) | ||||
| Palpitation | 2/1886 (0.1%) | 1/1872 (0.1%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Pericarditis | 1/1886 (0.1%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Peripheral gangrene | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Peripheral vascular disorder | 3/1886 (0.2%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Phlebitis | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Pulmonary embolus | 7/1886 (0.4%) | 3/1872 (0.2%) | 4/1849 (0.2%) | 4/1885 (0.2%) | ||||
| Pulmonary hypertension | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Retinal artery occlusion | 1/1886 (0.1%) | 0/1872 (0%) | 1/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Retinal vein thrombosis | 0/1886 (0%) | 2/1872 (0.1%) | 1/1849 (0.1%) | 2/1885 (0.1%) | ||||
| Shock | 3/1886 (0.2%) | 3/1872 (0.2%) | 2/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Sick sinus syndrome | 1/1886 (0.1%) | 2/1872 (0.1%) | 1/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Subarachnoid hemorrhage | 0/1886 (0%) | 2/1872 (0.1%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Supraventricular tachycardia | 3/1886 (0.2%) | 1/1872 (0.1%) | 0/1849 (0%) | 2/1885 (0.1%) | ||||
| Syncope | 8/1886 (0.4%) | 9/1872 (0.5%) | 4/1849 (0.2%) | 6/1885 (0.3%) | ||||
| Tachycardia | 0/1886 (0%) | 0/1872 (0%) | 2/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Tachycardia sinus | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Thrombophlebitis superficial | 4/1886 (0.2%) | 6/1872 (0.3%) | 3/1849 (0.2%) | 0/1885 (0%) | ||||
| Thrombosis | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Valvular heart disease | 3/1886 (0.2%) | 1/1872 (0.1%) | 2/1849 (0.1%) | 0/1885 (0%) | ||||
| Varicose vein | 8/1886 (0.4%) | 2/1872 (0.1%) | 3/1849 (0.2%) | 5/1885 (0.3%) | ||||
| Vascular disorder | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Vascular purpura | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Vasculitis | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Ventricular arrhythmia | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Ventricular extrasystoles | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Ventricular fibrillation | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Endocrine disorders | ||||||||
| Adh inappropriate | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Diabetes mellitus | 2/1886 (0.1%) | 5/1872 (0.3%) | 1/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Goiter | 4/1886 (0.2%) | 5/1872 (0.3%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Hyperthyroidism | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Hypothyroidism | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Parathyroid disorder | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 4/1885 (0.2%) | ||||
| Thyroid adenoma | 2/1886 (0.1%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Thyroid carcinoma | 5/1886 (0.3%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Thyroid disorder | 0/1886 (0%) | 3/1872 (0.2%) | 2/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Thyroid neoplasia | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Thyroiditis | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal distension | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Anorexia | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Biliary pain | 2/1886 (0.1%) | 2/1872 (0.1%) | 3/1849 (0.2%) | 1/1885 (0.1%) | ||||
| Blood in stool | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Carcinoma of mouth | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Cholangitis | 1/1886 (0.1%) | 1/1872 (0.1%) | 0/1849 (0%) | 2/1885 (0.1%) | ||||
| Cholecystitis | 12/1886 (0.6%) | 12/1872 (0.6%) | 6/1849 (0.3%) | 11/1885 (0.6%) | ||||
| Cholelithiasis | 21/1886 (1.1%) | 23/1872 (1.2%) | 13/1849 (0.7%) | 31/1885 (1.6%) | ||||
| Cholestatic jaundice | 0/1886 (0%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Cleft palate | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Colitis | 5/1886 (0.3%) | 9/1872 (0.5%) | 1/1849 (0.1%) | 6/1885 (0.3%) | ||||
| Constipation | 6/1886 (0.3%) | 4/1872 (0.2%) | 2/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Diarrhea | 1/1886 (0.1%) | 1/1872 (0.1%) | 0/1849 (0%) | 2/1885 (0.1%) | ||||
| Duodenal ulcer | 2/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 3/1885 (0.2%) | ||||
| Duodenal ulcer perforation | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Duodenitis | 0/1886 (0%) | 2/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Dysphagia | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Enteritis | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Enterocolitis | 3/1886 (0.2%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Esophageal stenosis | 0/1886 (0%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Esophagitis | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Fecal impaction | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 2/1885 (0.1%) | ||||
| Fecal incontinence | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Gastritis | 4/1886 (0.2%) | 1/1872 (0.1%) | 2/1849 (0.1%) | 2/1885 (0.1%) | ||||
| Gastroenteritis | 2/1886 (0.1%) | 1/1872 (0.1%) | 2/1849 (0.1%) | 4/1885 (0.2%) | ||||
| Gastroesophageal reflux disease | 1/1886 (0.1%) | 0/1872 (0%) | 1/1849 (0.1%) | 4/1885 (0.2%) | ||||
| Gastrointestinal carcinoma | 15/1886 (0.8%) | 13/1872 (0.7%) | 11/1849 (0.6%) | 17/1885 (0.9%) | ||||
| Gastrointestinal disorder | 5/1886 (0.3%) | 2/1872 (0.1%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Gastrointestinal hemorrhage | 3/1886 (0.2%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 3/1885 (0.2%) | ||||
| GI neoplasia | 4/1886 (0.2%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Hematemesis | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Hemorrhage of colon | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Hemorrhagic gastritis | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Hemorrhagic pancreatitis | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Hepatic neoplasia | 0/1886 (0%) | 3/1872 (0.2%) | 2/1849 (0.1%) | 0/1885 (0%) | ||||
| Hepatitis | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Hepatomegaly | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Hiatal hernia | 3/1886 (0.2%) | 2/1872 (0.1%) | 1/1849 (0.1%) | 2/1885 (0.1%) | ||||
| Ileitis | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Ileus | 1/1886 (0.1%) | 3/1872 (0.2%) | 2/1849 (0.1%) | 3/1885 (0.2%) | ||||
| Intestinal obstruction | 4/1886 (0.2%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 4/1885 (0.2%) | ||||
| Intestinal perforation | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Jaundice | 3/1886 (0.2%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Large intestine perforation | 2/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Liver damage | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Liver function tests abnormal | 3/1886 (0.2%) | 3/1872 (0.2%) | 1/1849 (0.1%) | 7/1885 (0.4%) | ||||
| Malabsorption syndrome | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Megacolon | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 2/1885 (0.1%) | ||||
| Nausea | 1/1886 (0.1%) | 2/1872 (0.1%) | 2/1849 (0.1%) | 3/1885 (0.2%) | ||||
| Pancreas disorder | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Pancreatitis | 1/1886 (0.1%) | 2/1872 (0.1%) | 3/1849 (0.2%) | 1/1885 (0.1%) | ||||
| Periodontitis | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Pyloric stenosis | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Rectal disorder | 11/1886 (0.6%) | 7/1872 (0.4%) | 1/1849 (0.1%) | 7/1885 (0.4%) | ||||
| Rectal hemorrhage | 1/1886 (0.1%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Sialadenitis | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Stomach ulcer | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 5/1885 (0.3%) | ||||
| Stomach ulcer hemorrhage | 1/1886 (0.1%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Ulcerative colitis | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Vomiting | 2/1886 (0.1%) | 3/1872 (0.2%) | 2/1849 (0.1%) | 7/1885 (0.4%) | ||||
| General disorders | ||||||||
| Abdominal pain | 7/1886 (0.4%) | 6/1872 (0.3%) | 8/1849 (0.4%) | 8/1885 (0.4%) | ||||
| Abdominal syndrome acute | 4/1886 (0.2%) | 9/1872 (0.5%) | 5/1849 (0.3%) | 5/1885 (0.3%) | ||||
| Abscess | 8/1886 (0.4%) | 2/1872 (0.1%) | 3/1849 (0.2%) | 3/1885 (0.2%) | ||||
| Accidental injury | 65/1886 (3.4%) | 50/1872 (2.7%) | 55/1849 (3%) | 61/1885 (3.2%) | ||||
| Accidental overdose | 4/1886 (0.2%) | 4/1872 (0.2%) | 5/1849 (0.3%) | 3/1885 (0.2%) | ||||
| Adenoma | 1/1886 (0.1%) | 2/1872 (0.1%) | 1/1849 (0.1%) | 2/1885 (0.1%) | ||||
| Allergic reaction | 0/1886 (0%) | 2/1872 (0.1%) | 1/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Anaphylactoid reaction | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Asthenia | 1/1886 (0.1%) | 2/1872 (0.1%) | 0/1849 (0%) | 3/1885 (0.2%) | ||||
| Back pain | 9/1886 (0.5%) | 4/1872 (0.2%) | 6/1849 (0.3%) | 4/1885 (0.2%) | ||||
| Carcinoma | 6/1886 (0.3%) | 5/1872 (0.3%) | 2/1849 (0.1%) | 2/1885 (0.1%) | ||||
| Cellulitis | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Chest pain | 6/1886 (0.3%) | 9/1872 (0.5%) | 10/1849 (0.5%) | 12/1885 (0.6%) | ||||
| Chest pain substernal | 3/1886 (0.2%) | 4/1872 (0.2%) | 0/1849 (0%) | 3/1885 (0.2%) | ||||
| Collagen disorder | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Cyst | 6/1886 (0.3%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Death | 0/1886 (0%) | 3/1872 (0.2%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Fever | 2/1886 (0.1%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 4/1885 (0.2%) | ||||
| Fibrosis | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| General physical health deterioration | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Headache | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Hernia | 9/1886 (0.5%) | 6/1872 (0.3%) | 9/1849 (0.5%) | 12/1885 (0.6%) | ||||
| Human immunodeficiency virus test positive | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Hormone level altered | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Hydrocephalus | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Hyperplasia | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Infection | 6/1886 (0.3%) | 10/1872 (0.5%) | 10/1849 (0.5%) | 10/1885 (0.5%) | ||||
| Lab test abnormal | 1/1886 (0.1%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Malaise | 1/1886 (0.1%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Neck pain | 2/1886 (0.1%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Neoplasm | 8/1886 (0.4%) | 6/1872 (0.3%) | 3/1849 (0.2%) | 9/1885 (0.5%) | ||||
| Non-specified drug reaction | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Overdose | 10/1886 (0.5%) | 8/1872 (0.4%) | 10/1849 (0.5%) | 10/1885 (0.5%) | ||||
| Pain | 2/1886 (0.1%) | 3/1872 (0.2%) | 5/1849 (0.3%) | 2/1885 (0.1%) | ||||
| Peritonitis | 3/1886 (0.2%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 2/1885 (0.1%) | ||||
| Sarcoma | 0/1886 (0%) | 2/1872 (0.1%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Sepsis | 3/1886 (0.2%) | 1/1872 (0.1%) | 2/1849 (0.1%) | 3/1885 (0.2%) | ||||
| Septic shock | 4/1886 (0.2%) | 0/1872 (0%) | 1/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Suicide attempt | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Abnormal vision | 1/1886 (0.1%) | 0/1872 (0%) | 1/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Blindness transient | 1/1886 (0.1%) | 2/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Cataract specified | 7/1886 (0.4%) | 2/1872 (0.1%) | 4/1849 (0.2%) | 1/1885 (0.1%) | ||||
| Deafness | 0/1886 (0%) | 1/1872 (0.1%) | 2/1849 (0.1%) | 0/1885 (0%) | ||||
| Ear disorder | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 2/1885 (0.1%) | ||||
| Eye disorder | 0/1886 (0%) | 2/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Eye hemorrhage | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Glaucoma | 2/1886 (0.1%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Keratitis | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Ophthalmitis | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Optic neuritis | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Otitis media | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Retinal degeneration | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 2/1885 (0.1%) | ||||
| Retinal detachment | 1/1886 (0.1%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Retinal disorder | 2/1886 (0.1%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Tinnitus | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Vestibular disorder | 0/1886 (0%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Vitreous disorder | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Reaction unevaluable | 0/1886 (0%) | 0/1872 (0%) | 2/1849 (0.1%) | 0/1885 (0%) | ||||
| Adverse event associated with miscellaneous factors | 6/1886 (0.3%) | 4/1872 (0.2%) | 4/1849 (0.2%) | 5/1885 (0.3%) | ||||
| Allergic reaction other than drug | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Device malfunction | 0/1886 (0%) | 0/1872 (0%) | 3/1849 (0.2%) | 0/1885 (0%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Acidosis | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Alkaline phosphatase increased | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 4/1885 (0.2%) | ||||
| Bilirubinemia | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Cachexia | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Dehydration | 2/1886 (0.1%) | 1/1872 (0.1%) | 3/1849 (0.2%) | 5/1885 (0.3%) | ||||
| Edema | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Electrolyte abnormality | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Healing abnormal | 3/1886 (0.2%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Hypercholesteremia | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Hyperglycemia | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Hyperlipemia | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Hypoglycemia | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Hypokalemia | 0/1886 (0%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 2/1885 (0.1%) | ||||
| Hyponatremia | 0/1886 (0%) | 2/1872 (0.1%) | 4/1849 (0.2%) | 1/1885 (0.1%) | ||||
| Obesity | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Peripheral edema | 3/1886 (0.2%) | 0/1872 (0%) | 2/1849 (0.1%) | 0/1885 (0%) | ||||
| Serum glutamic oxaloacetic transaminase increased | 1/1886 (0.1%) | 1/1872 (0.1%) | 0/1849 (0%) | 5/1885 (0.3%) | ||||
| Serum glutamic pyruvic transaminase increased | 2/1886 (0.1%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 7/1885 (0.4%) | ||||
| Weight gain | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Weight loss | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 5/1886 (0.3%) | 3/1872 (0.2%) | 7/1849 (0.4%) | 9/1885 (0.5%) | ||||
| Arthritis | 7/1886 (0.4%) | 4/1872 (0.2%) | 0/1849 (0%) | 4/1885 (0.2%) | ||||
| Arthrosis | 26/1886 (1.4%) | 25/1872 (1.3%) | 22/1849 (1.2%) | 23/1885 (1.2%) | ||||
| Bone disorder | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Bursitis | 1/1886 (0.1%) | 0/1872 (0%) | 1/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Chondrodystrophy | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Intervertebral disc protrusion | 0/1886 (0%) | 2/1872 (0.1%) | 0/1849 (0%) | 3/1885 (0.2%) | ||||
| Joint disorder | 0/1886 (0%) | 2/1872 (0.1%) | 1/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Leg cramps | 2/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Meniscus lesion | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Muscle spasms | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Musculoskeletal anomaly | 3/1886 (0.2%) | 9/1872 (0.5%) | 2/1849 (0.1%) | 4/1885 (0.2%) | ||||
| Myalgia | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 2/1885 (0.1%) | ||||
| Myasthenia | 1/1886 (0.1%) | 1/1872 (0.1%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Myopathy | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Rheumatoid arthritis | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Spinal fracture | 1/1886 (0.1%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Synovitis | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Tendinous contracture | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Tendon rupture | 1/1886 (0.1%) | 0/1872 (0%) | 1/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Tenosynovitis | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Nervous system disorders | ||||||||
| Addiction | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Alcoholism | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Amnesia | 3/1886 (0.2%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Anxiety | 1/1886 (0.1%) | 0/1872 (0%) | 1/1849 (0.1%) | 3/1885 (0.2%) | ||||
| Apathy | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Aphasia | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Carpal tunnel syndrome | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Central nervous system neoplasia | 0/1886 (0%) | 2/1872 (0.1%) | 3/1849 (0.2%) | 1/1885 (0.1%) | ||||
| Confusion | 0/1886 (0%) | 2/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Convulsion | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Dementia | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Depression | 3/1886 (0.2%) | 3/1872 (0.2%) | 2/1849 (0.1%) | 3/1885 (0.2%) | ||||
| Dizziness | 1/1886 (0.1%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 5/1885 (0.3%) | ||||
| Emotional lability | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Encephalopathy | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Extrapyramidal syndrome | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Facial paralysis | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Facial paresis | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Hallucinations | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Hemiplegia | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Hypesthesia | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Lumbar radiculopathy | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Manic depressive reaction | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Memory impairment | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Mental status changes | 0/1886 (0%) | 0/1872 (0%) | 2/1849 (0.1%) | 0/1885 (0%) | ||||
| Nerve compression | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 2/1885 (0.1%) | ||||
| Neuralgia | 2/1886 (0.1%) | 0/1872 (0%) | 2/1849 (0.1%) | 0/1885 (0%) | ||||
| Neuritis | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Neuropathy | 0/1886 (0%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Ophthalmoplegia | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Paralysis | 0/1886 (0%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Paresis | 3/1886 (0.2%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Paresthesia | 0/1886 (0%) | 0/1872 (0%) | 3/1849 (0.2%) | 1/1885 (0.1%) | ||||
| Parkinson's disease | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Personality disorder | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Radiculopathy nos | 1/1886 (0.1%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Somnolence | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Speech disorder | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Spinal cord compression | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Subdural hematoma | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Suicidal ideation | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Suicide | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Tremor | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Vertebrobasilar insufficiency | 4/1886 (0.2%) | 1/1872 (0.1%) | 0/1849 (0%) | 2/1885 (0.1%) | ||||
| Vertigo | 1/1886 (0.1%) | 2/1872 (0.1%) | 2/1849 (0.1%) | 4/1885 (0.2%) | ||||
| Renal and urinary disorders | ||||||||
| Acute kidney failure | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Anuria | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Bladder carcinoma | 2/1886 (0.1%) | 2/1872 (0.1%) | 2/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Bladder neoplasm | 0/1886 (0%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Breast carcinoma | 14/1886 (0.7%) | 9/1872 (0.5%) | 9/1849 (0.5%) | 11/1885 (0.6%) | ||||
| Breast cyst | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Breast disorder | 1/1886 (0.1%) | 3/1872 (0.2%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Breast enlargement | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Breast neoplasm | 1/1886 (0.1%) | 5/1872 (0.3%) | 1/1849 (0.1%) | 2/1885 (0.1%) | ||||
| Cervix carcinoma | 0/1886 (0%) | 1/1872 (0.1%) | 3/1849 (0.2%) | 0/1885 (0%) | ||||
| Cervix carcinoma in situ | 2/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Cervix disorder | 1/1886 (0.1%) | 1/1872 (0.1%) | 2/1849 (0.1%) | 2/1885 (0.1%) | ||||
| Cervix neoplasm | 2/1886 (0.1%) | 1/1872 (0.1%) | 2/1849 (0.1%) | 3/1885 (0.2%) | ||||
| Cystitis | 0/1886 (0%) | 4/1872 (0.2%) | 0/1849 (0%) | 2/1885 (0.1%) | ||||
| Dysuria | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Endometrial carcinoma | 0/1886 (0%) | 3/1872 (0.2%) | 2/1849 (0.1%) | 7/1885 (0.4%) | ||||
| Endometrial disorder | 2/1886 (0.1%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Endometrial hyperplasia | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Endometrial neoplasia | 5/1886 (0.3%) | 4/1872 (0.2%) | 3/1849 (0.2%) | 6/1885 (0.3%) | ||||
| Genital leukoplakia | 1/1886 (0.1%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Hematuria | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Hydronephrosis | 1/1886 (0.1%) | 3/1872 (0.2%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Kidney calculus | 4/1886 (0.2%) | 1/1872 (0.1%) | 0/1849 (0%) | 2/1885 (0.1%) | ||||
| Kidney failure | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Kidney function abnormal | 1/1886 (0.1%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Ovarian carcinoma | 5/1886 (0.3%) | 1/1872 (0.1%) | 4/1849 (0.2%) | 0/1885 (0%) | ||||
| Ovarian cyst | 4/1886 (0.2%) | 1/1872 (0.1%) | 3/1849 (0.2%) | 5/1885 (0.3%) | ||||
| Ovarian disorder | 3/1886 (0.2%) | 1/1872 (0.1%) | 2/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Ovarian germ cell teratoma benign | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Pyelonephritis | 7/1886 (0.4%) | 3/1872 (0.2%) | 1/1849 (0.1%) | 3/1885 (0.2%) | ||||
| Urinary incontinence | 6/1886 (0.3%) | 4/1872 (0.2%) | 7/1849 (0.4%) | 9/1885 (0.5%) | ||||
| Urinary retention | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Urinary tract disorder | 9/1886 (0.5%) | 9/1872 (0.5%) | 8/1849 (0.4%) | 8/1885 (0.4%) | ||||
| Urinary tract infection | 6/1886 (0.3%) | 2/1872 (0.1%) | 2/1849 (0.1%) | 3/1885 (0.2%) | ||||
| Urination impaired | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Urogenital anomaly | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Urogenital disorder | 1/1886 (0.1%) | 0/1872 (0%) | 1/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Urolithiasis | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Uterine disorder | 7/1886 (0.4%) | 10/1872 (0.5%) | 7/1849 (0.4%) | 9/1885 (0.5%) | ||||
| Uterine fibroids enlarged | 1/1886 (0.1%) | 0/1872 (0%) | 2/1849 (0.1%) | 2/1885 (0.1%) | ||||
| Vaginitis | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Vulvovaginal disorder | 2/1886 (0.1%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 5/1885 (0.3%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Asthma | 3/1886 (0.2%) | 3/1872 (0.2%) | 2/1849 (0.1%) | 3/1885 (0.2%) | ||||
| Bronchiectasis | 0/1886 (0%) | 1/1872 (0.1%) | 2/1849 (0.1%) | 0/1885 (0%) | ||||
| Bronchitis | 5/1886 (0.3%) | 3/1872 (0.2%) | 4/1849 (0.2%) | 3/1885 (0.2%) | ||||
| Carcinoma of lung | 4/1886 (0.2%) | 3/1872 (0.2%) | 5/1849 (0.3%) | 5/1885 (0.3%) | ||||
| Chronic obstructive airways disease | 6/1886 (0.3%) | 8/1872 (0.4%) | 5/1849 (0.3%) | 7/1885 (0.4%) | ||||
| Cough increased | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 2/1885 (0.1%) | ||||
| Dyspnea | 1/1886 (0.1%) | 1/1872 (0.1%) | 3/1849 (0.2%) | 1/1885 (0.1%) | ||||
| Emphysema | 0/1886 (0%) | 0/1872 (0%) | 2/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Epistaxis | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Hemoptysis | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Hemothorax | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Laryngeal neoplasia | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Laryngitis | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Lung disorder | 2/1886 (0.1%) | 4/1872 (0.2%) | 3/1849 (0.2%) | 2/1885 (0.1%) | ||||
| Lung edema | 3/1886 (0.2%) | 0/1872 (0%) | 1/1849 (0.1%) | 2/1885 (0.1%) | ||||
| Pharyngitis | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Pleural disorder | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Pleural effusion | 0/1886 (0%) | 0/1872 (0%) | 4/1849 (0.2%) | 1/1885 (0.1%) | ||||
| Pleuritic pain | 0/1886 (0%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Pneumonia | 21/1886 (1.1%) | 19/1872 (1%) | 15/1849 (0.8%) | 23/1885 (1.2%) | ||||
| Pneumonitis | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Pneumothorax | 1/1886 (0.1%) | 1/1872 (0.1%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Respiratory disorder | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Respiratory distress syndrome | 0/1886 (0%) | 1/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Respiratory failure | 2/1886 (0.1%) | 3/1872 (0.2%) | 0/1849 (0%) | 2/1885 (0.1%) | ||||
| Sinusitis | 1/1886 (0.1%) | 0/1872 (0%) | 1/1849 (0.1%) | 1/1885 (0.1%) | ||||
| Upper respiratory infection | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Atelectasis | 2/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Dermatitis allergic | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Discoid lupus erythematosus | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Fungal dermatitis | 0/1886 (0%) | 0/1872 (0%) | 1/1849 (0.1%) | 0/1885 (0%) | ||||
| Pruritus | 1/1886 (0.1%) | 1/1872 (0.1%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Psoriasis | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Rash | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Skin benign neoplasm | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Skin carcinoma | 18/1886 (1%) | 33/1872 (1.8%) | 14/1849 (0.8%) | 23/1885 (1.2%) | ||||
| Skin disorder | 0/1886 (0%) | 2/1872 (0.1%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Skin melanoma | 3/1886 (0.2%) | 3/1872 (0.2%) | 2/1849 (0.1%) | 3/1885 (0.2%) | ||||
| Skin necrosis | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Skin ulcer | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Subcutaneous nodule | 0/1886 (0%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Sweating | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 1/1885 (0.1%) | ||||
| Urticaria | 1/1886 (0.1%) | 0/1872 (0%) | 0/1849 (0%) | 0/1885 (0%) | ||||
| Local reaction to procedure | 5/1886 (0.3%) | 3/1872 (0.2%) | 0/1849 (0%) | 3/1885 (0.2%) | ||||
| Surgical and medical procedures | ||||||||
| Surgical procedure | 1/1886 (0.1%) | 1/1872 (0.1%) | 0/1849 (0%) | 2/1885 (0.1%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Bazedoxifene 20 mg | Bazedoxifene 40/ 20 mg | Raloxifene 60 mg (Core Study) | Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1818/1886 (96.4%) | 1800/1872 (96.2%) | 1775/1849 (96%) | 1823/1885 (96.7%) | ||||
| Cardiac disorders | ||||||||
| Hypertension | 495/1886 (26.2%) | 482/1872 (25.7%) | 412/1849 (22.3%) | 475/1885 (25.2%) | ||||
| Vasodilatation | 247/1886 (13.1%) | 253/1872 (13.5%) | 227/1849 (12.3%) | 127/1885 (6.7%) | ||||
| Gastrointestinal disorders | ||||||||
| Anorexia | 80/1886 (4.2%) | 72/1872 (3.8%) | 100/1849 (5.4%) | 97/1885 (5.1%) | ||||
| Constipation | 383/1886 (20.3%) | 373/1872 (19.9%) | 344/1849 (18.6%) | 358/1885 (19%) | ||||
| Diarrhea | 196/1886 (10.4%) | 237/1872 (12.7%) | 221/1849 (12%) | 217/1885 (11.5%) | ||||
| Dyspepsia | 215/1886 (11.4%) | 202/1872 (10.8%) | 185/1849 (10%) | 223/1885 (11.8%) | ||||
| Gastritis | 127/1886 (6.7%) | 106/1872 (5.7%) | 100/1849 (5.4%) | 93/1885 (4.9%) | ||||
| Gastroenteritis | 93/1886 (4.9%) | 103/1872 (5.5%) | 80/1849 (4.3%) | 96/1885 (5.1%) | ||||
| Nausea | 177/1886 (9.4%) | 176/1872 (9.4%) | 158/1849 (8.5%) | 176/1885 (9.3%) | ||||
| Vomiting | 120/1886 (6.4%) | 118/1872 (6.3%) | 119/1849 (6.4%) | 137/1885 (7.3%) | ||||
| General disorders | ||||||||
| Abdominal pain | 460/1886 (24.4%) | 460/1872 (24.6%) | 460/1849 (24.9%) | 509/1885 (27%) | ||||
| Accidental injury | 503/1886 (26.7%) | 449/1872 (24%) | 406/1849 (22%) | 522/1885 (27.7%) | ||||
| Asthenia | 234/1886 (12.4%) | 230/1872 (12.3%) | 220/1849 (11.9%) | 226/1885 (12%) | ||||
| Back pain | 676/1886 (35.8%) | 652/1872 (34.8%) | 632/1849 (34.2%) | 674/1885 (35.8%) | ||||
| Chest pain | 181/1886 (9.6%) | 170/1872 (9.1%) | 156/1849 (8.4%) | 156/1885 (8.3%) | ||||
| Flu syndrome | 536/1886 (28.4%) | 523/1872 (27.9%) | 529/1849 (28.6%) | 559/1885 (29.7%) | ||||
| Headache | 469/1886 (24.9%) | 468/1872 (25%) | 427/1849 (23.1%) | 471/1885 (25%) | ||||
| Infection | 526/1886 (27.9%) | 514/1872 (27.5%) | 462/1849 (25%) | 516/1885 (27.4%) | ||||
| Neck pain | 176/1886 (9.3%) | 174/1872 (9.3%) | 153/1849 (8.3%) | 188/1885 (10%) | ||||
| Pain | 643/1886 (34.1%) | 616/1872 (32.9%) | 615/1849 (33.3%) | 659/1885 (35%) | ||||
| Cataract specified | 119/1886 (6.3%) | 121/1872 (6.5%) | 91/1849 (4.9%) | 126/1885 (6.7%) | ||||
| Adverse event associated with miscellaneous factors | 111/1886 (5.9%) | 86/1872 (4.6%) | 92/1849 (5%) | 115/1885 (6.1%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Hypercholesteremia | 211/1886 (11.2%) | 162/1872 (8.7%) | 115/1849 (6.2%) | 231/1885 (12.3%) | ||||
| Hyperglycemia | 118/1886 (6.3%) | 102/1872 (5.4%) | 82/1849 (4.4%) | 131/1885 (6.9%) | ||||
| Hyperlipemia | 139/1886 (7.4%) | 125/1872 (6.7%) | 97/1849 (5.2%) | 133/1885 (7.1%) | ||||
| Peripheral edema | 239/1886 (12.7%) | 217/1872 (11.6%) | 208/1849 (11.2%) | 192/1885 (10.2%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 679/1886 (36%) | 660/1872 (35.3%) | 643/1849 (34.8%) | 662/1885 (35.1%) | ||||
| Arthrosis | 192/1886 (10.2%) | 200/1872 (10.7%) | 172/1849 (9.3%) | 200/1885 (10.6%) | ||||
| Leg cramps | 265/1886 (14.1%) | 264/1872 (14.1%) | 240/1849 (13%) | 204/1885 (10.8%) | ||||
| Myalgia | 102/1886 (5.4%) | 90/1872 (4.8%) | 116/1849 (6.3%) | 114/1885 (6%) | ||||
| Nervous system disorders | ||||||||
| Anxiety | 101/1886 (5.4%) | 106/1872 (5.7%) | 108/1849 (5.8%) | 137/1885 (7.3%) | ||||
| Depression | 142/1886 (7.5%) | 158/1872 (8.4%) | 124/1849 (6.7%) | 131/1885 (6.9%) | ||||
| Dizziness | 232/1886 (12.3%) | 198/1872 (10.6%) | 176/1849 (9.5%) | 212/1885 (11.2%) | ||||
| Insomnia | 193/1886 (10.2%) | 173/1872 (9.2%) | 166/1849 (9%) | 202/1885 (10.7%) | ||||
| Paresthesia | 103/1886 (5.5%) | 110/1872 (5.9%) | 83/1849 (4.5%) | 108/1885 (5.7%) | ||||
| Vertigo | 171/1886 (9.1%) | 141/1872 (7.5%) | 149/1849 (8.1%) | 167/1885 (8.9%) | ||||
| Renal and urinary disorders | ||||||||
| Breast disorder | 135/1886 (7.2%) | 137/1872 (7.3%) | 109/1849 (5.9%) | 153/1885 (8.1%) | ||||
| Cervix disorder | 138/1886 (7.3%) | 174/1872 (9.3%) | 146/1849 (7.9%) | 183/1885 (9.7%) | ||||
| Cystitis | 111/1886 (5.9%) | 121/1872 (6.5%) | 106/1849 (5.7%) | 102/1885 (5.4%) | ||||
| Dysuria | 88/1886 (4.7%) | 95/1872 (5.1%) | 80/1849 (4.3%) | 89/1885 (4.7%) | ||||
| Urinary tract infection | 223/1886 (11.8%) | 214/1872 (11.4%) | 209/1849 (11.3%) | 211/1885 (11.2%) | ||||
| Vaginitis | 117/1886 (6.2%) | 111/1872 (5.9%) | 102/1849 (5.5%) | 143/1885 (7.6%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Bronchitis | 209/1886 (11.1%) | 218/1872 (11.6%) | 158/1849 (8.5%) | 193/1885 (10.2%) | ||||
| Cough increased | 251/1886 (13.3%) | 231/1872 (12.3%) | 192/1849 (10.4%) | 234/1885 (12.4%) | ||||
| Pharyngitis | 171/1886 (9.1%) | 192/1872 (10.3%) | 166/1849 (9%) | 213/1885 (11.3%) | ||||
| Pneumonia | 87/1886 (4.6%) | 91/1872 (4.9%) | 83/1849 (4.5%) | 103/1885 (5.5%) | ||||
| Sinusitis | 125/1886 (6.6%) | 119/1872 (6.4%) | 111/1849 (6%) | 112/1885 (5.9%) | ||||
| Upper respiratory infection | 167/1886 (8.9%) | 156/1872 (8.3%) | 127/1849 (6.9%) | 151/1885 (8%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Pruritus | 144/1886 (7.6%) | 139/1872 (7.4%) | 129/1849 (7%) | 143/1885 (7.6%) | ||||
| Rash | 85/1886 (4.5%) | 87/1872 (4.6%) | 79/1849 (4.3%) | 98/1885 (5.2%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00205777
Other Study ID Numbers:
- 3068A1-301
- B1781001
First Posted:
Sep 20, 2005
Last Update Posted:
Apr 10, 2013
Last Verified:
Feb 1, 2013