A Study to Evaluate the Safety, Tolerability, and Efficacy of Odanacatib (MK-0822) in Postmenopausal Women Previously Treated With a Bisphosphonate (MK-0822-042)
Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00885170
Collaborator
(none)
246
2
29.1
Study Details
Study Description
Brief Summary
The study will evaluate the both the efficacy of odanacatib on Bone Mineral Density (BMD) and the safety of odanacatib for postmenopausal osteoporosis in patients previously treated with alendronate. The primary hypothesis of the trial is that treatment with odanacatib 50 mg once weekly will increase bone mineral density at the femoral neck compared to placebo at the end of 24 months.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
246 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase IIa Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Overall Safety in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With Alendronate
Actual Study Start Date
:
Apr 13, 2009
Actual Primary Completion Date
:
Sep 15, 2011
Actual Study Completion Date
:
Sep 15, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Odanacatib 50 mg Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg. |
Drug: Odanacatib
Odanacatib 50 mg tablets once weekly for 24 months
Dietary Supplement: Vitamin D3
Vitamin D3, two 2800 IU tablets, taken once weekly for 24 months
Dietary Supplement: Calcium
Participants will receive calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.
|
| Placebo Comparator: Placebo Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg. |
Drug: Placebo
Placebo to odanacatib 50 mg tablets once weekly for 24 months
Dietary Supplement: Vitamin D3
Vitamin D3, two 2800 IU tablets, taken once weekly for 24 months
Dietary Supplement: Calcium
Participants will receive calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.
|
Outcome Measures
Primary Outcome Measures
- Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Month 24 [Baseline and Month 24]
BMD at the femoral neck was assessed by dual-energy X-ray absorptiometry (DXA) at baseline and Month 24.
- Percentage of Participants Experiencing One or More Adverse Events (AEs) [Up to 25 months]
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.
- Percentage of Participants Discontinuing Study Drug Due to an AE [Up to 24 months]
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.
Secondary Outcome Measures
- Percent Change From Baseline in Femoral Neck BMD at Month 12 [Baseline and 12 Months]
BMD at the femoral neck was assessed by DXA at baseline and Month 12.
- Percent Change From Baseline in Trochanter BMD at Month 24 [Baseline and 24 Months]
BMD at the trochanter was assessed by DXA at baseline and Month 24.
- Percent Change From Baseline in Trochanter BMD at Month 12 [Baseline and 12 Months]
BMD at the trochanter was assessed by DXA at baseline and Month 12.
- Percent Change From Baseline in Total Hip BMD at Month 24 [Baseline and 24 Months]
BMD at the total hip was assessed by DXA at baseline and Month 24.
- Percent Change From Baseline in Total Hip BMD at Month 12 [Baseline and 12 Months]
BMD at the total hip was assessed by DXA at baseline and Month 12.
- Percent Change From Baseline in Lumbar Spine BMD at Month 24 [Baseline and 24 Months]
BMD at the lumbar spine was assessed by DXA at baseline and Month 24.
- Percent Change From Baseline in Lumbar Spine BMD at Month 12 [Baseline and 12 Months]
BMD at the lumbar spine was assessed by DXA at baseline and Month 12.
- Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 24 [Baseline and 24 Months]
BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 24.
- Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 12 [Baseline and 12 Months]
BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 12.
- Percent Change From Baseline in Log-Transformed Serum C-Telopeptides of Type I Collagen (s-CTx) at Month 24 [Baseline and Month 24]
s-CTx is a biochemical marker of bone resorption.
- Percent Change From Baseline in Log-Transformed s-CTx at Month 12 [Baseline and Month 12]
s-CTx is a biochemical marker of bone resorption.
- Percent Change From Baseline in Log-Transformed Urine N-Telopeptides/Creatinine Ratio at Month 24 [Baseline and Month 24]
N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio (u-NTx/Cr) is a biochemical marker of bone resorption.
- Percent Change From Baseline in Log-Transformed u-NTx/Cr at Month 12 [Baseline and Month 12]
u-NTx/Cr is a biochemical marker of bone resorption.
- Percent Change From Baseline in Log-Transformed Serum Bone-Specific Alkaline Phosphatase at Month 24 [Baseline and Month 24]
Bone-Specific Alkaline Phosphatase (BSAP) is a biochemical marker of bone formation.
- Percent Change From Baseline in Log-Transformed Serum BSAP at Month 12 [Baseline and Month 12]
BSAP is a biochemical marker of bone formation.
- Percent Change From Baseline in Log-Transformed Serum N-Terminal Propeptide of Type I Collagen at Month 24 [Baseline and Month 24]
Serum N-terminal propeptide of Type I collagen (s-P1NP) is a biochemical marker of bone formation.
- Percent Change From Baseline in Log-Transformed Serum N-terminal Propeptide of Type I Collagen at Month 12 [Baseline and Month 12]
s-P1NP is a biochemical marker of bone formation.
- Percent Change From Baseline in Log-Transformed Serum Calcium at Month 24 [Baseline and Month 24]
Serum calcium is an index of calcium homeostasis.
- Percent Change From Baseline in Log-Transformed Serum Phosphate at Month 24 [Baseline and Month 24]
Serum phosphate is an index of mineral homeostasis.
- Percent Change From Baseline in Log-Transformed Serum Parathyroid Hormone at Month 24 [Baseline and Month 24]
Serum parathyroid hormone (SPH) regulates calcium, phosphorus, and vitamin D levels in the blood.
- Percent Change From Baseline in Log-Transformed Serum 1,25 Dihydroxyvitamin D at Month 24 [Baseline and Month 24]
1,25 dihydroxyvitamin D [1,25(OH)2 D] is the active vitamin D metabolite and stimulates calcium absorption in the intestine.
- Percent Change From Baseline in Log-Transformed Serum 25-Hydroxyvitamin D at Month 24 [Baseline and Month 24]
The 25-hydroxy vitamin D [25(OH)D] test is the most accurate way to measure vitamin D. In the kidney, 25-hydroxy vitamin D is converted into 1,25 di-hydroxyvitamin D, the active vitamin D metabolite.
Eligibility Criteria
Criteria
Ages Eligible for Study:
60 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Has been postmenopausal for at least 5 years
-
Has taken or is taking alendronate
-
Agrees not to use medications for osteoporosis other than what is provided by the study
Exclusion Criteria:
-
Has a history or evidence of hip fracture
-
Has a history of cancer within 5 years of screening, except certain skin or cervical cancers.
-
Has active parathyroid disease
-
Has a history of thyroid disease not adequately controlled by medication
-
Is taking anti-seizure medication and has abnormal calcium metabolism
-
Has received any bisphosphonate other than alendronate for 20% of the last 3 years, or within 3 months of screening
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Monitor, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:
NCT00885170
Other Study ID Numbers:
- 0822-042
- 2009_578
- CTRI/2009/091/000218
- 2008-008257-30
First Posted:
Apr 21, 2009
Last Update Posted:
Aug 28, 2018
Last Verified:
Jul 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled and treated in 40 study centers located in the United States, Europe, South Africa, and Asia-Pacific. |
|---|---|
| Pre-assignment Detail | Women ≥ 60 years of age who had been on, or were on, an alendronate therapy for postmenopausal osteoporosis were eligible to participate in this trial. |
| Arm/Group Title | Odanacatib 50 mg | Placebo |
|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| Period Title: Overall Study | ||
| STARTED | 124 | 122 |
| Treated | 122 | 121 |
| COMPLETED | 86 | 99 |
| NOT COMPLETED | 38 | 23 |
Baseline Characteristics
| Arm/Group Title | Odanacatib 50 mg | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Total of all reporting groups |
| Overall Participants | 122 | 121 | 243 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
71.5
(6.7)
|
71.1
(6.8)
|
71.3
(6.8)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
122
100%
|
121
100%
|
243
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Baseline DEXA Areal Bone Mineral Density T-score (T-score) [Mean (Standard Deviation) ] | |||
| Femoral Neck BMD T-score (122, 121, 243) |
-2.35
(0.52)
|
-2.38
(0.48)
|
-2.36
(0.50)
|
| Hip Trochanter BMD T-score (122, 121, 243) |
-1.91
(0.70)
|
-2.10
(0.79)
|
-2.00
(0.75)
|
| Total Hip BMD T-score (122, 121, 243) |
-1.91
(0.62)
|
-2.05
(0.68)
|
-1.98
(0.65)
|
| Lumbar Spine BMD T-score (113, 116, 229) |
-2.34
(1.10)
|
-2.49
(1.14)
|
-2.41
(1.12)
|
| 1/3 Distal Forearm BMD T-score (114, 113, 227) |
-2.62
(1.26)
|
-2.69
(1.10)
|
-2.65
(1.18)
|
| Baseline Biochemical Markers of Bone Resorption and Bone Formation (ng/mL) [Mean (Standard Deviation) ] | |||
| C-telopeptides of Type 1 collage (116, 117,233) |
0.19
(0.22)
|
0.18
(0.14)
|
0.19
(0.19)
|
| Serum bone specific alk. phosphatase (115,117,232) |
9.28
(4.63)
|
9.41
(4.16)
|
9.35
(4.39)
|
| Serum N-propeptide, T1 collagen (115, 117, 232) |
29.48
(28.18)
|
27.79
(21.58)
|
28.63
(25.03)
|
| Urine N-Telopeptides/Creatinine Ratio (nmol/mmol) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [nmol/mmol] |
26.00
(23.76)
|
26.35
(18.08)
|
26.17
(21.08)
|
Outcome Measures
| Title | Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Month 24 |
|---|---|
| Description | BMD at the femoral neck was assessed by dual-energy X-ray absorptiometry (DXA) at baseline and Month 24. |
| Time Frame | Baseline and Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all randomized, treated participants who had femoral neck BMD data at Baseline and Month 24. |
| Arm/Group Title | Odanacatib 50 mg | Placebo |
|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| Measure Participants | 83 | 95 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
1.73
|
-0.94
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Odanacatib 50 mg, Placebo |
|---|---|---|
| Comments | The primary hypothesis of the study was met if; in postmenopausal women previously treated with alendronate with low BMD, two years of treatment with odanacatib 50 mg significantly increased BMD at the femoral neck site compared to placebo (p-value < 0.001). | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Constrained longitudinal data analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in the Least Squares Means |
| Estimated Value | 2.67 | |
| Confidence Interval |
(2-Sided) 95% 1.17 to 4.17 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, >5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction | |
| Title | Percentage of Participants Experiencing One or More Adverse Events (AEs) |
|---|---|
| Description | An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. |
| Time Frame | Up to 25 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took. |
| Arm/Group Title | Odanacatib 50 mg | Placebo |
|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| Measure Participants | 122 | 121 |
| Number [Percentage of participants] |
68.0
55.7%
|
73.6
60.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Odanacatib 50 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Percentages vs. Placebo |
| Estimated Value | -5.5 | |
| Confidence Interval |
(2-Sided) 95% -16.9 to 6.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Based on Miettinen & Nurminen method. | |
| Title | Percentage of Participants Discontinuing Study Drug Due to an AE |
|---|---|
| Description | An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. |
| Time Frame | Up to 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took. |
| Arm/Group Title | Odanacatib 50 mg | Placebo |
|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| Measure Participants | 122 | 121 |
| Number [Percentage of participants] |
9.0
7.4%
|
3.3
2.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Odanacatib 50 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in the Percentage vs. Placebo |
| Estimated Value | 5.7 | |
| Confidence Interval |
(2-Sided) 95% -0.4 to 12.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Based on Miettinen & Nurminen method. | |
| Title | Percent Change From Baseline in Femoral Neck BMD at Month 12 |
|---|---|
| Description | BMD at the femoral neck was assessed by DXA at baseline and Month 12. |
| Time Frame | Baseline and 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all randomized, treated participants who had femoral neck BMD data at Baseline and Month 12. |
| Arm/Group Title | Odanacatib 50 mg | Placebo |
|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| Measure Participants | 98 | 109 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
0.60
|
-0.28
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Odanacatib 50 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.166 |
| Comments | ||
| Method | Constrained longitudinal data analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in the least Squares Means |
| Estimated Value | 0.88 | |
| Confidence Interval |
(2-Sided) 95% -0.37 to 2.14 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, >5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction | |
| Title | Percent Change From Baseline in Trochanter BMD at Month 24 |
|---|---|
| Description | BMD at the trochanter was assessed by DXA at baseline and Month 24. |
| Time Frame | Baseline and 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all randomized, treated participants who had trochanter BMD data at Baseline and Month 24. |
| Arm/Group Title | Odanacatib 50 mg | Placebo |
|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| Measure Participants | 83 | 95 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
1.83
|
-1.35
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Odanacatib 50 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | Constrained longitudinal data analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in the Least Squares Means |
| Estimated Value | 3.18 | |
| Confidence Interval |
(2-Sided) 95% 1.19 to 5.17 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, >5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction | |
| Title | Percent Change From Baseline in Trochanter BMD at Month 12 |
|---|---|
| Description | BMD at the trochanter was assessed by DXA at baseline and Month 12. |
| Time Frame | Baseline and 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all randomized, treated participants who had trochanter BMD data at Baseline and Month 12. |
| Arm/Group Title | Odanacatib 50 mg | Placebo |
|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| Measure Participants | 98 | 109 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
0.86
|
-0.14
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Odanacatib 50 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.142 |
| Comments | ||
| Method | Constrained longitudinal data analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in the Least Squares Means |
| Estimated Value | 1.00 | |
| Confidence Interval |
(2-Sided) 95% -0.34 to 2.35 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, >5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction | |
| Title | Percent Change From Baseline in Total Hip BMD at Month 24 |
|---|---|
| Description | BMD at the total hip was assessed by DXA at baseline and Month 24. |
| Time Frame | Baseline and 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all randomized, treated participants who had total hip BMD data at Baseline and Month 24. |
| Arm/Group Title | Odanacatib 50 mg | Placebo |
|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| Measure Participants | 83 | 95 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
0.83
|
-1.87
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Odanacatib 50 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | cLDA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in the Least Squares Means |
| Estimated Value | 2.70 | |
| Confidence Interval |
(2-Sided) 95% 1.41 to 4.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, >5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction | |
| Title | Percent Change From Baseline in Total Hip BMD at Month 12 |
|---|---|
| Description | BMD at the total hip was assessed by DXA at baseline and Month 12. |
| Time Frame | Baseline and 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all randomized, treated participants who had total hip BMD data at Baseline and Month 12. |
| Arm/Group Title | Odanacatib 50 mg | Placebo |
|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| Measure Participants | 98 | 109 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
0.26
|
-0.80
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Odanacatib 50 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.023 |
| Comments | ||
| Method | cLDA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in the Least Squares Means |
| Estimated Value | 1.06 | |
| Confidence Interval |
(2-Sided) 95% 0.15 to 1.98 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, >5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction | |
| Title | Percent Change From Baseline in Lumbar Spine BMD at Month 24 |
|---|---|
| Description | BMD at the lumbar spine was assessed by DXA at baseline and Month 24. |
| Time Frame | Baseline and 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all randomized, treated participants who had lumbar spine BMD data at Baseline and Month 24. |
| Arm/Group Title | Odanacatib 50 mg | Placebo |
|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| Measure Participants | 80 | 89 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
2.28
|
-0.30
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Odanacatib 50 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | cLDA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in the Least Squares Means |
| Estimated Value | 2.57 | |
| Confidence Interval |
(2-Sided) 95% 1.26 to 3.89 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, >5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction | |
| Title | Percent Change From Baseline in Lumbar Spine BMD at Month 12 |
|---|---|
| Description | BMD at the lumbar spine was assessed by DXA at baseline and Month 12. |
| Time Frame | Baseline and 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all randomized, treated participants who had lumbar spine BMD data at Baseline and Month 12. |
| Arm/Group Title | Odanacatib 50 mg | Placebo |
|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| Measure Participants | 91 | 103 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
0.69
|
-0.12
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Odanacatib 50 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.103 |
| Comments | ||
| Method | cLDA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in the Least Squares Means |
| Estimated Value | 0.80 | |
| Confidence Interval |
(2-Sided) 95% -0.16 to 1.77 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, >5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction | |
| Title | Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 24 |
|---|---|
| Description | BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 24. |
| Time Frame | Baseline and 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all randomized, treated participants who had 1/3 distal forearm BMD data at Baseline and Month 24. |
| Arm/Group Title | Odanacatib 50 mg | Placebo |
|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| Measure Participants | 80 | 86 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
-0.92
|
-1.14
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Odanacatib 50 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.763 |
| Comments | ||
| Method | cLDA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in the Least Squares Means |
| Estimated Value | 0.22 | |
| Confidence Interval |
(2-Sided) 95% -1.23 to 1.67 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, >5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction | |
| Title | Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 12 |
|---|---|
| Description | BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 12. |
| Time Frame | Baseline and 12 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all randomized, treated participants who had 1/3 distal forearm BMD data at Baseline and Month 12. |
| Arm/Group Title | Odanacatib 50 mg | Placebo |
|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| Measure Participants | 93 | 100 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
-0.11
|
-0.49
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Odanacatib 50 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.578 |
| Comments | ||
| Method | cLDA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in the Least Squares Means |
| Estimated Value | 0.38 | |
| Confidence Interval |
(2-Sided) 95% -0.96 to 1.72 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, >5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction | |
| Title | Percent Change From Baseline in Log-Transformed Serum C-Telopeptides of Type I Collagen (s-CTx) at Month 24 |
|---|---|
| Description | s-CTx is a biochemical marker of bone resorption. |
| Time Frame | Baseline and Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all randomized, treated participants who had s-CTx data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history. |
| Arm/Group Title | Odanacatib 50 mg | Placebo |
|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| Measure Participants | 80 | 79 |
| Least Squares Mean (95% Confidence Interval) [Percent change] |
93.86
|
83.70
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Odanacatib 50 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.500 |
| Comments | ||
| Method | cLDA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in the Least Squares Means |
| Estimated Value | 10.16 | |
| Confidence Interval |
(2-Sided) 95% -19.39 to 39.72 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions. | |
| Title | Percent Change From Baseline in Log-Transformed s-CTx at Month 12 |
|---|---|
| Description | s-CTx is a biochemical marker of bone resorption. |
| Time Frame | Baseline and Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all randomized, treated participants who had s-CTx data at Baseline and Month 12 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history. |
| Arm/Group Title | Odanacatib 50 mg | Placebo |
|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| Measure Participants | 91 | 100 |
| Least Squares Mean (95% Confidence Interval) [Percent change] |
62.27
|
68.09
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Odanacatib 50 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.709 |
| Comments | ||
| Method | cLDA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in the Least Squares Means |
| Estimated Value | -5.82 | |
| Confidence Interval |
(2-Sided) 95% -36.29 to 24.65 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions. | |
| Title | Percent Change From Baseline in Log-Transformed Urine N-Telopeptides/Creatinine Ratio at Month 24 |
|---|---|
| Description | N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio (u-NTx/Cr) is a biochemical marker of bone resorption. |
| Time Frame | Baseline and Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all randomized, treated participants who had u-NTx/Cr data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history. |
| Arm/Group Title | Odanacatib 50 mg | Placebo |
|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| Measure Participants | 80 | 77 |
| Least Squares Mean (95% Confidence Interval) [Percent change] |
-15.55
|
31.48
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Odanacatib 50 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | cLDA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in the Least Squares Means |
| Estimated Value | -47.04 | |
| Confidence Interval |
(2-Sided) 95% -62.40 to -31.67 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions. | |
| Title | Percent Change From Baseline in Log-Transformed u-NTx/Cr at Month 12 |
|---|---|
| Description | u-NTx/Cr is a biochemical marker of bone resorption. |
| Time Frame | Baseline and Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all randomized, treated participants who had u-NTx/Cr data at Baseline and Month 12 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history. |
| Arm/Group Title | Odanacatib 50 mg | Placebo |
|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| Measure Participants | 91 | 96 |
| Least Squares Mean (95% Confidence Interval) [Percent change] |
-17.23
|
29.06
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Odanacatib 50 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | cLDA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in the Least Squares Means |
| Estimated Value | -46.29 | |
| Confidence Interval |
(2-Sided) 95% -61.43 to -31.15 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions. | |
| Title | Percent Change From Baseline in Log-Transformed Serum Bone-Specific Alkaline Phosphatase at Month 24 |
|---|---|
| Description | Bone-Specific Alkaline Phosphatase (BSAP) is a biochemical marker of bone formation. |
| Time Frame | Baseline and Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all randomized, treated participants who had BSAP data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history. |
| Arm/Group Title | Odanacatib 50 mg | Placebo |
|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| Measure Participants | 82 | 84 |
| Least Squares Mean (95% Confidence Interval) [Percent change] |
51.62
|
40.65
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Odanacatib 50 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.186 |
| Comments | ||
| Method | cLDA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in the Least Squares Means |
| Estimated Value | 10.96 | |
| Confidence Interval |
(2-Sided) 95% -5.29 to 27.22 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions. | |
| Title | Percent Change From Baseline in Log-Transformed Serum BSAP at Month 12 |
|---|---|
| Description | BSAP is a biochemical marker of bone formation. |
| Time Frame | Baseline and Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all randomized, treated participants who had BSAP data at Baseline and Month 12 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history. |
| Arm/Group Title | Odanacatib 50 mg | Placebo |
|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| Measure Participants | 94 | 101 |
| Least Squares Mean (95% Confidence Interval) [Percent change] |
30.91
|
18.10
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Odanacatib 50 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.015 |
| Comments | ||
| Method | cLDA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in the Least Squares Means |
| Estimated Value | 12.82 | |
| Confidence Interval |
(2-Sided) 95% 2.54 to 23.10 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions. | |
| Title | Percent Change From Baseline in Log-Transformed Serum N-Terminal Propeptide of Type I Collagen at Month 24 |
|---|---|
| Description | Serum N-terminal propeptide of Type I collagen (s-P1NP) is a biochemical marker of bone formation. |
| Time Frame | Baseline and Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all randomized, treated participants who had S-P1NP data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history. |
| Arm/Group Title | Odanacatib 50 mg | Placebo |
|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| Measure Participants | 82 | 85 |
| Least Squares Mean (95% Confidence Interval) [Percent change] |
90.70
|
59.53
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Odanacatib 50 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.011 |
| Comments | ||
| Method | cLDA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in the Least Squares Means |
| Estimated Value | 31.17 | |
| Confidence Interval |
(2-Sided) 95% 7.13 to 55.21 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions. | |
| Title | Percent Change From Baseline in Log-Transformed Serum N-terminal Propeptide of Type I Collagen at Month 12 |
|---|---|
| Description | s-P1NP is a biochemical marker of bone formation. |
| Time Frame | Baseline and Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all randomized, treated participants who had S-P1NP data at Baseline and Month 12 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history. |
| Arm/Group Title | Odanacatib 50 mg | Placebo |
|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| Measure Participants | 94 | 101 |
| Least Squares Mean (95% Confidence Interval) [Percent change] |
80.37
|
56.37
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Odanacatib 50 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.059 |
| Comments | ||
| Method | cLDA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in the Least Squares Means |
| Estimated Value | 24.01 | |
| Confidence Interval |
(2-Sided) 95% -0.93 to 48.94 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions. | |
| Title | Percent Change From Baseline in Log-Transformed Serum Calcium at Month 24 |
|---|---|
| Description | Serum calcium is an index of calcium homeostasis. |
| Time Frame | Baseline and Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all randomized, treated participants who had serum calcium data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history. |
| Arm/Group Title | Odanacatib 50 mg | Placebo |
|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| Measure Participants | 83 | 87 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
-2.40
|
-2.51
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Odanacatib 50 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.846 |
| Comments | ||
| Method | cLDA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in the Least Squares Means |
| Estimated Value | 0.11 | |
| Confidence Interval |
(2-Sided) 95% -0.95 to 1.16 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions. | |
| Title | Percent Change From Baseline in Log-Transformed Serum Phosphate at Month 24 |
|---|---|
| Description | Serum phosphate is an index of mineral homeostasis. |
| Time Frame | Baseline and Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all randomized, treated participants who had serum phosphate data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history. |
| Arm/Group Title | Odanacatib 50 mg | Placebo |
|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| Measure Participants | 83 | 86 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
2.37
|
0.99
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Odanacatib 50 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.413 |
| Comments | ||
| Method | cLDA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in the Least Squares Means |
| Estimated Value | 1.38 | |
| Confidence Interval |
(2-Sided) 95% -1.91 to 4.67 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions. | |
| Title | Percent Change From Baseline in Log-Transformed Serum Parathyroid Hormone at Month 24 |
|---|---|
| Description | Serum parathyroid hormone (SPH) regulates calcium, phosphorus, and vitamin D levels in the blood. |
| Time Frame | Baseline and Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all randomized, treated participants who had SPH data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history. |
| Arm/Group Title | Odanacatib 50 mg | Placebo |
|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| Measure Participants | 81 | 85 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
4.38
|
10.28
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Odanacatib 50 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.326 |
| Comments | ||
| Method | cLDA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in the Least Squares Means |
| Estimated Value | -5.91 | |
| Confidence Interval |
(2-Sided) 95% -17.66 to 5.85 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions. | |
| Title | Percent Change From Baseline in Log-Transformed Serum 1,25 Dihydroxyvitamin D at Month 24 |
|---|---|
| Description | 1,25 dihydroxyvitamin D [1,25(OH)2 D] is the active vitamin D metabolite and stimulates calcium absorption in the intestine. |
| Time Frame | Baseline and Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all randomized, treated participants who had 1,25(OH)2 D data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history. |
| Arm/Group Title | Odanacatib 50 mg | Placebo |
|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| Measure Participants | 80 | 84 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
-5.23
|
-6.71
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Odanacatib 50 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.835 |
| Comments | ||
| Method | cLDA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in the Least Squares Means |
| Estimated Value | 1.47 | |
| Confidence Interval |
(2-Sided) 95% -12.37 to 15.32 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions. | |
| Title | Percent Change From Baseline in Log-Transformed Serum 25-Hydroxyvitamin D at Month 24 |
|---|---|
| Description | The 25-hydroxy vitamin D [25(OH)D] test is the most accurate way to measure vitamin D. In the kidney, 25-hydroxy vitamin D is converted into 1,25 di-hydroxyvitamin D, the active vitamin D metabolite. |
| Time Frame | Baseline and Month 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all randomized, treated participants who had 25(OH)D data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history. |
| Arm/Group Title | Odanacatib 50 mg | Placebo |
|---|---|---|
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. |
| Measure Participants | 81 | 86 |
| Least Squares Mean (95% Confidence Interval) [Percent Change] |
-2.57
|
0.57
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Odanacatib 50 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.376 |
| Comments | ||
| Method | cLDA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in the Least Squares Means |
| Estimated Value | -3.13 | |
| Confidence Interval |
(2-Sided) 95% -10.04 to 3.78 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions. | |
Adverse Events
| Time Frame | Up to 25 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The APaT population included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took. | |||
| Arm/Group Title | Odanacatib 50 mg | Placebo | ||
| Arm/Group Description | Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg. | ||
All Cause Mortality |
||||
| Odanacatib 50 mg | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Odanacatib 50 mg | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 20/122 (16.4%) | 20/121 (16.5%) | ||
| Blood and lymphatic system disorders | ||||
| Thrombocytopenia | 1/122 (0.8%) | 1 | 0/121 (0%) | 0 |
| Cardiac disorders | ||||
| Aortic valve stenosis | 0/122 (0%) | 0 | 1/121 (0.8%) | 1 |
| Atrial fibrillation | 0/122 (0%) | 0 | 2/121 (1.7%) | 2 |
| Cardiac failure | 1/122 (0.8%) | 1 | 0/121 (0%) | 0 |
| Coronary artery disease | 0/122 (0%) | 0 | 1/121 (0.8%) | 1 |
| Mitral valve disease | 0/122 (0%) | 0 | 1/121 (0.8%) | 1 |
| Nodal rhythm | 0/122 (0%) | 0 | 1/121 (0.8%) | 1 |
| Eye disorders | ||||
| Pterygium | 0/122 (0%) | 0 | 1/121 (0.8%) | 1 |
| Gastrointestinal disorders | ||||
| Abdominal pain | 0/122 (0%) | 0 | 1/121 (0.8%) | 1 |
| Colitis | 0/122 (0%) | 0 | 1/121 (0.8%) | 1 |
| Gastritis | 1/122 (0.8%) | 1 | 0/121 (0%) | 0 |
| Lower gastrointestinal haemorrhage | 1/122 (0.8%) | 1 | 0/121 (0%) | 0 |
| Melaena | 0/122 (0%) | 0 | 1/121 (0.8%) | 1 |
| General disorders | ||||
| Chest pain | 2/122 (1.6%) | 2 | 1/121 (0.8%) | 1 |
| Death | 0/122 (0%) | 0 | 1/121 (0.8%) | 1 |
| Infections and infestations | ||||
| Erysipelas | 0/122 (0%) | 0 | 1/121 (0.8%) | 1 |
| Herpes zoster infection neurological | 1/122 (0.8%) | 1 | 0/121 (0%) | 0 |
| Urinary tract infection | 0/122 (0%) | 0 | 1/121 (0.8%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Ankle fracture | 1/122 (0.8%) | 1 | 0/121 (0%) | 0 |
| Femur fracture | 4/122 (3.3%) | 4 | 1/121 (0.8%) | 1 |
| Fractured sacrum | 0/122 (0%) | 0 | 1/121 (0.8%) | 1 |
| Hip fracture | 0/122 (0%) | 0 | 2/121 (1.7%) | 2 |
| Humerus fracture | 0/122 (0%) | 0 | 1/121 (0.8%) | 1 |
| Joint dislocation | 0/122 (0%) | 0 | 1/121 (0.8%) | 1 |
| Lumbar vertebral fracture | 1/122 (0.8%) | 1 | 1/121 (0.8%) | 1 |
| Radius fracture | 1/122 (0.8%) | 1 | 1/121 (0.8%) | 2 |
| Rib fracture | 1/122 (0.8%) | 1 | 0/121 (0%) | 0 |
| Sternal fracture | 1/122 (0.8%) | 1 | 0/121 (0%) | 0 |
| Wrist fracture | 0/122 (0%) | 0 | 1/121 (0.8%) | 1 |
| Metabolism and nutrition disorders | ||||
| Hypokalaemia | 0/122 (0%) | 0 | 1/121 (0.8%) | 1 |
| Hyponatraemia | 1/122 (0.8%) | 1 | 0/121 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Intervertebral disc protrusion | 0/122 (0%) | 0 | 1/121 (0.8%) | 1 |
| Tenosynovitis | 1/122 (0.8%) | 1 | 0/121 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Adenocarcinoma | 1/122 (0.8%) | 1 | 0/121 (0%) | 0 |
| Basal cell carcinoma | 1/122 (0.8%) | 1 | 1/121 (0.8%) | 1 |
| Breast fibroma | 0/122 (0%) | 0 | 1/121 (0.8%) | 1 |
| Glioblastoma | 1/122 (0.8%) | 1 | 0/121 (0%) | 0 |
| Metastases to liver | 1/122 (0.8%) | 1 | 0/121 (0%) | 0 |
| Metastatic neoplasm | 1/122 (0.8%) | 1 | 0/121 (0%) | 0 |
| Nervous system disorders | ||||
| Cerebral haemorrhage | 0/122 (0%) | 0 | 1/121 (0.8%) | 1 |
| Dementia | 0/122 (0%) | 0 | 1/121 (0.8%) | 1 |
| Lacunar infarction | 1/122 (0.8%) | 1 | 0/121 (0%) | 0 |
| Presyncope | 0/122 (0%) | 0 | 1/121 (0.8%) | 1 |
| Sciatica | 1/122 (0.8%) | 1 | 0/121 (0%) | 0 |
| Psychiatric disorders | ||||
| Depression | 0/122 (0%) | 0 | 1/121 (0.8%) | 1 |
| Renal and urinary disorders | ||||
| Renal failure acute | 0/122 (0%) | 0 | 1/121 (0.8%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Epistaxis | 0/122 (0%) | 0 | 1/121 (0.8%) | 1 |
| Interstitial lung disease | 0/122 (0%) | 0 | 1/121 (0.8%) | 1 |
| Vascular disorders | ||||
| Deep vein thrombosis | 0/122 (0%) | 0 | 1/121 (0.8%) | 1 |
| Hypertension | 0/122 (0%) | 0 | 2/121 (1.7%) | 2 |
Other (Not Including Serious) Adverse Events |
||||
| Odanacatib 50 mg | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 40/122 (32.8%) | 48/121 (39.7%) | ||
| Infections and infestations | ||||
| Bronchitis | 7/122 (5.7%) | 9 | 5/121 (4.1%) | 5 |
| Nasopharyngitis | 4/122 (3.3%) | 4 | 8/121 (6.6%) | 9 |
| Urinary tract infection | 15/122 (12.3%) | 18 | 20/121 (16.5%) | 28 |
| Injury, poisoning and procedural complications | ||||
| Fall | 2/122 (1.6%) | 4 | 7/121 (5.8%) | 8 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 11/122 (9%) | 13 | 14/121 (11.6%) | 14 |
| Back pain | 14/122 (11.5%) | 15 | 13/121 (10.7%) | 16 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
Results Point of Contact
| Name/Title | Senior Vice President, Global Clinical Development |
|---|---|
| Organization | Merck Sharp & Dohme Corp. |
| Phone | 1-800-672-6372 |
| ClinicalTrialsDisclosure@merck.com |
Responsible Party:
Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:
NCT00885170
Other Study ID Numbers:
- 0822-042
- 2009_578
- CTRI/2009/091/000218
- 2008-008257-30
First Posted:
Apr 21, 2009
Last Update Posted:
Aug 28, 2018
Last Verified:
Jul 1, 2018