EuroGIOPS: Comparison of the Effects of 2 Drugs on Lumbar Spine Volumetric BMD in Men With Glucocorticoid-Induced Osteoporosis
Study Details
Study Description
Brief Summary
The objective of this study is to test the hypothesis that teriparatide is superior to the active comparator in the change from baseline to 18 months of lumbar spine volumetric trabecular bone mineral density (BMD) in males with glucocorticoid-induced osteoporosis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
This study is a multinational, European, multicenter, randomized, open-label, active comparator controlled study with 2 study periods: a screening phase of up to 6 weeks, and an open-label treatment phase of 18 months. Approximately 100 adult men with osteoporosis associated with sustained glucocorticoid therapy will be enrolled into the study. Approximately one-half of the participants (at all investigational sites) will be randomized to teriparatide 20 micrograms/day (ug/day given as a subcutaneous (sc) injection), and the other half randomized to risedronate 35 milligrams (mg) once weekly (QW) oral (po) tablet. All participants will receive approximately 1000 mg/day elemental calcium and 800 to 1200 international units per day (IU/day) of vitamin D.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Teriparatide Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD). |
Drug: Teriparatide
20 µg/day sc for 18 months
Other Names:
|
| Active Comparator: Risedronate Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW) |
Drug: Risedronate
35 mg/week po for 18 months
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Tomography (QCT) at 18 Months [Baseline, 18 months]
Least Squares (LS) Means were adjusted for age, baseline serum aminoterminal propeptide of Type I procollagen (P1NP), fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.
Secondary Outcome Measures
- Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Technology (QCT) at 6 Months [Baseline, 6 months]
Least Squares (LS) Means were adjusted for age, baseline propeptide of Type I procollagen (P1NP), fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.
- Change From Baseline in High Resolution Quantitative Computerized Technology (HR-QCT) of Integral and Trabecular Bone Mineral Density (BMD) of the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months [Baseline, 6 months, 18 months]
Three-dimensional (3-D) microstructure variables of T12 were assessed by HR-QCT. In contrast with regular QCT that assessed 3 millimeter (mm) slide thickness, HR-QCT used segmentation of 1 single vertebra with approximately 100 consecutive slides reconstructed at 300-400 micrometer (µm) slice increments covering the complete vertebral body. Least Squares (LS) Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.
- Change From Baseline in Anterior Bending and Axial Torsion by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength [Baseline, 6 months, 18 months]
Anterior bending and axial torsion were measured using HR-QCT-based finite element analysis to determine stiffness and strength of T12. Stiffness evaluated strength of the vertebral body, defined as the slope of the initial step of the force-displacement curve. Strength of the vertebral body was evaluated under compressive loading conditions using computer simulation. LS Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.
- Change From Baseline in Axial Compression by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength [Baseline, 6 months, 18 months]
Axial compression was measured using HR-QCT-based finite element analysis to determine stiffness and strength of T12. Stiffness evaluated the strength of the vertebral body, defined as the slope of the initial step of the force-displacement curve. Strength of the vertebral body was evaluated under compressive loading conditions using computer simulation. LS Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.
- Change From Baseline in Areal Bone Mineral Density (BMD) at Lumbar Spine, Femoral Neck, and Total Hip at 18 Months [Baseline, 18 months]
Dual x-ray absorptiometry (DXA) techniques validated this measurement at skeletal sites that are at risk of osteoporotic fracture, such as lumbar spine, femoral neck, and hip.
- Change From Baseline in Serum Aminoterminal Propeptide of Type I Procollagen (P1NP) at 3 Months, 6 Months, and 18 Months [Baseline, 3 months, 6 months, 18 months]
P1NP was used as a serum biochemical marker of collagen synthesis, reflecting the formation of new osteoid.
- Change From Baseline in Serum Type I Collagen Degradation Fragments (β-CTx) at 3 Months, 6 Months, and 18 Months [3, 6, 18 months]
β-CTx was used as a biochemical marker of bone turnover/resorption, reflecting collagen breakdown of the bone matrix.
- Number of Participants With Adverse Events (AEs) [Baseline up to 18 months]
Summary tables of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module. Fractures that occurred during the study were collected separately as an additional safety variable. The number of participants experiencing hypercalcemia was summarized for each treatment arm. Hypercalcemia was defined as a serum calcium level corrected for albumin of >2.7 millimole per liter (mmol/L) (10.8 milligram per deciliter [mg/dL]).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Ambulatory men 25 years of age and older presenting to Visit 1 with a bone mineral density (BMD) of at least 1.5 standard deviation (SD) below the corresponding normal young adult men average BMD (T score of -1.5 or lower), as determined from the manufacturer's database at any of the following regions of interest: total hip, femoral neck, or lumbar spine
-
Have received glucocorticoid therapy at an average dose of at least 5.0 milligrams (mg) per day of prednisone or its equivalent for a minimum of 3 consecutive months immediately preceding screening (Visit 1), as determined by medical history.
-
A minimum of 2 lumbar vertebrae (L) in the L-1 through L-3 region must be evaluable by quantitative computerized tomography.
-
Normal or clinically insignificant abnormal laboratory values (as determined by the investigator) including serum calcium, parathyroid hormone (PTH) (1 84), and 25 hydroxyvitamin D concentrations, and alkaline phosphatase activity.
Exclusion Criteria:
-
Presence of a mild, moderate, or severe spinal fracture in both the twelfth thoracic vertebra (T-12) and first lumbar vertebra (L-1), as determined by the central reading facility using the semiquantitative technique.
-
Abnormal albumin-corrected serum calcium levels
-
History of unresolved skeletal diseases that affect bone metabolism other than glucocorticoid-induced osteoporosis
-
History of malignant neoplasms in the 5 years prior to Visit 2, with the exception of superficial basal cell or squamous cell carcinomas of the skin that have been definitively treated. Increased baseline risk of osteosarcoma; this includes patients with Paget's disease of the bone, previous primary skeletal malignancy, or skeletal exposure to therapeutic irradiation.
-
Abnormal thyroid function not corrected by therapy
-
Past and/or current treatment with certain medications.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bad Nauheim | Germany | 61231 | |
| 2 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Frankfurt | Germany | 60528 | |
| 3 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hamburg | Germany | 22415 | |
| 4 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Heinsberg | Germany | 52525 | |
| 5 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Leverkusen | Germany | 51375 | |
| 6 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Magdeburg | Germany | 39110 | |
| 7 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Potsdam | Germany | 14469 | |
| 8 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kifissia | Greece | 14561 | |
| 9 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Thessaloniki | Greece | 56429 | |
| 10 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rome | Italy | 00161 | |
| 11 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Siena | Italy | 53100 | |
| 12 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Barcelona | Spain | 08907 | |
| 13 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Madrid | Spain | 28046 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 11716
- B3D-EW-GHDH
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Of the 174 participants who were enrolled into the study, 92 were eligible and randomly assigned to the treatment arms. |
| Arm/Group Title | Teriparatide | Risedronate |
|---|---|---|
| Arm/Group Description | Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD) | Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW) |
| Period Title: Overall Study | ||
| STARTED | 45 | 47 |
| COMPLETED | 38 | 39 |
| NOT COMPLETED | 7 | 8 |
Baseline Characteristics
| Arm/Group Title | Teriparatide | Risedronate | Total |
|---|---|---|---|
| Arm/Group Description | Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD) | Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW) | Total of all reporting groups |
| Overall Participants | 45 | 47 | 92 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
57.5
(12.80)
|
55.1
(15.54)
|
56.3
(14.24)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
0
0%
|
0
0%
|
0
0%
|
| Male |
45
100%
|
47
100%
|
92
100%
|
| Race/Ethnicity, Customized (participants) [Number] | |||
| Caucasian |
44
97.8%
|
46
97.9%
|
90
97.8%
|
| Hispanic |
0
0%
|
1
2.1%
|
1
1.1%
|
| East Asian |
1
2.2%
|
0
0%
|
1
1.1%
|
| Region of Enrollment (participants) [Number] | |||
| Germany |
19
42.2%
|
21
44.7%
|
40
43.5%
|
| Greece |
6
13.3%
|
6
12.8%
|
12
13%
|
| Italy |
5
11.1%
|
8
17%
|
13
14.1%
|
| Spain |
15
33.3%
|
12
25.5%
|
27
29.3%
|
| Number of participants with fractures before study (participants) [Number] | |||
| With fractures |
19
42.2%
|
17
36.2%
|
36
39.1%
|
| Without fractures |
26
57.8%
|
30
63.8%
|
56
60.9%
|
Outcome Measures
| Title | Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Tomography (QCT) at 18 Months |
|---|---|
| Description | Least Squares (LS) Means were adjusted for age, baseline serum aminoterminal propeptide of Type I procollagen (P1NP), fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial. |
| Time Frame | Baseline, 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population was the primary efficacy population, which included all randomized participants who received at least 1 dose of study medication (full analysis set) and had a lumbar spine volumetric trabecular BMD measurement at baseline and at ≥1 post-baseline visit. |
| Arm/Group Title | Teriparatide | Risedronate |
|---|---|---|
| Arm/Group Description | Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD) | Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW) |
| Measure Participants | 39 | 40 |
| Least Squares Mean (Standard Error) [milligram per cubic centimeter (mg/cm^3)] |
12.28
(3.16)
|
2.94
(3.14)
|
| Title | Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Technology (QCT) at 6 Months |
|---|---|
| Description | Least Squares (LS) Means were adjusted for age, baseline propeptide of Type I procollagen (P1NP), fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial. |
| Time Frame | Baseline, 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population was the primary efficacy population, which included all randomized participants who received at least 1 dose of study medication (full analysis set) and had a lumbar spine volumetric trabecular BMD measurement at baseline and at ≥1 post-baseline visit. |
| Arm/Group Title | Teriparatide | Risedronate |
|---|---|---|
| Arm/Group Description | Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD) | Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW) |
| Measure Participants | 39 | 40 |
| Least Squares Mean (Standard Error) [milligram per cubic centimeter (mg/cm^3)] |
4.31
(3.15)
|
2.52
(3.16)
|
| Title | Change From Baseline in High Resolution Quantitative Computerized Technology (HR-QCT) of Integral and Trabecular Bone Mineral Density (BMD) of the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months |
|---|---|
| Description | Three-dimensional (3-D) microstructure variables of T12 were assessed by HR-QCT. In contrast with regular QCT that assessed 3 millimeter (mm) slide thickness, HR-QCT used segmentation of 1 single vertebra with approximately 100 consecutive slides reconstructed at 300-400 micrometer (µm) slice increments covering the complete vertebral body. Least Squares (LS) Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial. |
| Time Frame | Baseline, 6 months, 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication. |
| Arm/Group Title | Teriparatide | Risedronate |
|---|---|---|
| Arm/Group Description | Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD) | Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW) |
| Measure Participants | 39 | 40 |
| Integral BMD at 6 months |
-0.42
(6.42)
|
-1.91
(7.11)
|
| Integral BMD at 18 months |
10.72
(6.22)
|
0.68
(7.08)
|
| Trabecular BMD at 6 months |
-0.70
(5.26)
|
-0.87
(5.85)
|
| Trabecular BMD at 18 months |
9.53
(5.09)
|
0.22
(5.82)
|
| Title | Change From Baseline in Anterior Bending and Axial Torsion by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength |
|---|---|
| Description | Anterior bending and axial torsion were measured using HR-QCT-based finite element analysis to determine stiffness and strength of T12. Stiffness evaluated strength of the vertebral body, defined as the slope of the initial step of the force-displacement curve. Strength of the vertebral body was evaluated under compressive loading conditions using computer simulation. LS Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial. |
| Time Frame | Baseline, 6 months, 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication. |
| Arm/Group Title | Teriparatide | Risedronate |
|---|---|---|
| Arm/Group Description | Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD) | Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW) |
| Measure Participants | 39 | 40 |
| Anterior bending stiffness at 6 months |
664969.0
(317684.0)
|
415705.0
(323135.0)
|
| Anterior bending stiffness at 18 months |
1209225.0
(300977.0)
|
233283.0
(322829.0)
|
| Axial torsion stiffness at 6 months |
142902.9
(71714.2)
|
77830.7
(72947.9)
|
| Axial torsion stiffness at 18 months |
279392.8
(68284.5)
|
56639.3
(72946.9)
|
| Anterior bending strength at 6 months |
12490.9
(8405.0)
|
8827.2
(8741.0)
|
| Anterior bending strength at 18 months |
26046.4
(8304.1)
|
4822.0
(8686.6)
|
| Axial torsion strength at 6 months |
6127.7
(4132.3)
|
3664.0
(4233.5)
|
| Axial torsion strength at 18 months |
14181.3
(3954.4)
|
2545.8
(4228.7)
|
| Title | Change From Baseline in Axial Compression by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength |
|---|---|
| Description | Axial compression was measured using HR-QCT-based finite element analysis to determine stiffness and strength of T12. Stiffness evaluated the strength of the vertebral body, defined as the slope of the initial step of the force-displacement curve. Strength of the vertebral body was evaluated under compressive loading conditions using computer simulation. LS Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial. |
| Time Frame | Baseline, 6 months, 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication. |
| Arm/Group Title | Teriparatide | Risedronate |
|---|---|---|
| Arm/Group Description | Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD) | Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW) |
| Measure Participants | 39 | 40 |
| Axial compression stiffness at 6 months |
890.7
(596.6)
|
407.6
(607.6)
|
| Axial compression stiffness at 18 months |
1973.9
(569.0)
|
363.7
(605.9)
|
| Axial compression strength at 6 months |
580.7
(444.6)
|
313.6
(457.0)
|
| Axial compression strength at 18 months |
1287.5
(424.0)
|
209.4
(455.5)
|
| Title | Change From Baseline in Areal Bone Mineral Density (BMD) at Lumbar Spine, Femoral Neck, and Total Hip at 18 Months |
|---|---|
| Description | Dual x-ray absorptiometry (DXA) techniques validated this measurement at skeletal sites that are at risk of osteoporotic fracture, such as lumbar spine, femoral neck, and hip. |
| Time Frame | Baseline, 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication. |
| Arm/Group Title | Teriparatide | Risedronate |
|---|---|---|
| Arm/Group Description | Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD) | Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW) |
| Measure Participants | 45 | 47 |
| Lumbar spine (n=38; n=39) |
0.068
(0.0685)
|
0.037
(0.0493)
|
| Hip (n=38; n=37) |
0.014
(0.0319)
|
0.007
(0.0320)
|
| Femoral neck (n=38; n=37) |
0.014
(0.0446)
|
-0.007
(0.0333)
|
| Title | Change From Baseline in Serum Aminoterminal Propeptide of Type I Procollagen (P1NP) at 3 Months, 6 Months, and 18 Months |
|---|---|
| Description | P1NP was used as a serum biochemical marker of collagen synthesis, reflecting the formation of new osteoid. |
| Time Frame | Baseline, 3 months, 6 months, 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication. |
| Arm/Group Title | Teriparatide | Risedronate |
|---|---|---|
| Arm/Group Description | Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD) | Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW) |
| Measure Participants | 45 | 47 |
| P1NP at 3 months |
27.33
(8.32)
|
-16.09
(7.82)
|
| P1NP at 6 months |
52.55
(8.27)
|
-16.50
(7.95)
|
| P1NP at 18 months |
28.48
(8.74)
|
-15.58
(8.58)
|
| Title | Change From Baseline in Serum Type I Collagen Degradation Fragments (β-CTx) at 3 Months, 6 Months, and 18 Months |
|---|---|
| Description | β-CTx was used as a biochemical marker of bone turnover/resorption, reflecting collagen breakdown of the bone matrix. |
| Time Frame | 3, 6, 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication. |
| Arm/Group Title | Teriparatide | Risedronate |
|---|---|---|
| Arm/Group Description | Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD) | Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW) |
| Measure Participants | 45 | 47 |
| β-CTx at 3 months |
0.12
(0.07)
|
-0.15
(0.07)
|
| β-CTx at 6 months |
0.25
(0.07)
|
-0.14
(0.07)
|
| β-CTx at 18 months |
0.03
(0.08)
|
-0.11
(0.07)
|
| Title | Number of Participants With Adverse Events (AEs) |
|---|---|
| Description | Summary tables of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module. Fractures that occurred during the study were collected separately as an additional safety variable. The number of participants experiencing hypercalcemia was summarized for each treatment arm. Hypercalcemia was defined as a serum calcium level corrected for albumin of >2.7 millimole per liter (mmol/L) (10.8 milligram per deciliter [mg/dL]). |
| Time Frame | Baseline up to 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set included all participants who received study treatment. |
| Arm/Group Title | Teriparatide | Risedronate |
|---|---|---|
| Arm/Group Description | Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD) | Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW) |
| Measure Participants | 45 | 47 |
| Serious Adverse Events (SAEs) |
13
28.9%
|
22
46.8%
|
| Other Non-serious AEs |
22
48.9%
|
30
63.8%
|
| Fractures |
0
0%
|
5
10.6%
|
| Hypercalcemia |
0
0%
|
0
0%
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Teriparatide | Risedronate | ||
| Arm/Group Description | Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD) | Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW) | ||
All Cause Mortality |
||||
| Teriparatide | Risedronate | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Teriparatide | Risedronate | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/45 (28.9%) | 22/47 (46.8%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 1/45 (2.2%) | 1 | 0/47 (0%) | 0 |
| Cardiac disorders | ||||
| Angina pectoris | 0/45 (0%) | 0 | 1/47 (2.1%) | 1 |
| Aortic valve incompetence | 1/45 (2.2%) | 1 | 0/47 (0%) | 0 |
| Atrial fibrillation | 0/45 (0%) | 0 | 1/47 (2.1%) | 1 |
| Cardiac failure | 0/45 (0%) | 0 | 1/47 (2.1%) | 1 |
| Ear and labyrinth disorders | ||||
| Sudden hearing loss | 0/45 (0%) | 0 | 1/47 (2.1%) | 1 |
| Eye disorders | ||||
| Cataract | 1/45 (2.2%) | 1 | 0/47 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Anal fistula | 0/45 (0%) | 0 | 1/47 (2.1%) | 2 |
| Crohn's disease | 0/45 (0%) | 0 | 2/47 (4.3%) | 2 |
| Gastrointestinal haemorrhage | 1/45 (2.2%) | 1 | 0/47 (0%) | 0 |
| Pancreatitis acute | 0/45 (0%) | 0 | 1/47 (2.1%) | 1 |
| General disorders | ||||
| Chest pain | 0/45 (0%) | 0 | 1/47 (2.1%) | 1 |
| Sudden death | 1/45 (2.2%) | 1 | 0/47 (0%) | 0 |
| Hepatobiliary disorders | ||||
| Cholecystitis | 0/45 (0%) | 0 | 1/47 (2.1%) | 1 |
| Infections and infestations | ||||
| Anal abscess | 0/45 (0%) | 0 | 1/47 (2.1%) | 1 |
| Cytomegalovirus infection | 1/45 (2.2%) | 1 | 0/47 (0%) | 0 |
| Intervertebral discitis | 0/45 (0%) | 0 | 1/47 (2.1%) | 1 |
| Postoperative abscess | 0/45 (0%) | 0 | 1/47 (2.1%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Ankle fracture | 0/45 (0%) | 0 | 1/47 (2.1%) | 1 |
| Fall | 0/45 (0%) | 0 | 2/47 (4.3%) | 2 |
| Femoral neck fracture | 0/45 (0%) | 0 | 1/47 (2.1%) | 1 |
| Head injury | 0/45 (0%) | 0 | 1/47 (2.1%) | 1 |
| Procedural pain | 1/45 (2.2%) | 1 | 0/47 (0%) | 0 |
| Radius fracture | 0/45 (0%) | 0 | 1/47 (2.1%) | 1 |
| Rib fracture | 0/45 (0%) | 0 | 1/47 (2.1%) | 4 |
| Musculoskeletal and connective tissue disorders | ||||
| Intervertebral disc protrusion | 3/45 (6.7%) | 3 | 0/47 (0%) | 0 |
| Osteoarthritis | 1/45 (2.2%) | 1 | 0/47 (0%) | 0 |
| Rheumatoid arthritis | 0/45 (0%) | 0 | 1/47 (2.1%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Intestinal adenocarcinoma | 0/45 (0%) | 0 | 1/47 (2.1%) | 1 |
| Prostatic adenoma | 0/45 (0%) | 0 | 1/47 (2.1%) | 1 |
| Seminoma | 0/45 (0%) | 0 | 1/47 (2.1%) | 1 |
| Nervous system disorders | ||||
| Cognitive disorder | 0/45 (0%) | 0 | 1/47 (2.1%) | 1 |
| Renal and urinary disorders | ||||
| Nephrolithiasis | 0/45 (0%) | 0 | 1/47 (2.1%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute respiratory failure | 1/45 (2.2%) | 1 | 0/47 (0%) | 0 |
| Asthma | 0/45 (0%) | 0 | 1/47 (2.1%) | 1 |
| Chronic obstructive pulmonary disease | 2/45 (4.4%) | 2 | 3/47 (6.4%) | 3 |
| Dyspnoea | 1/45 (2.2%) | 1 | 0/47 (0%) | 0 |
| Epistaxis | 0/45 (0%) | 0 | 1/47 (2.1%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Leukoplakia | 1/45 (2.2%) | 1 | 0/47 (0%) | 0 |
| Scar | 0/45 (0%) | 0 | 1/47 (2.1%) | 1 |
| Skin ulcer | 0/45 (0%) | 0 | 1/47 (2.1%) | 1 |
| Vascular disorders | ||||
| Femoral artery occlusion | 0/45 (0%) | 0 | 1/47 (2.1%) | 1 |
| Hypertensive crisis | 0/45 (0%) | 0 | 2/47 (4.3%) | 3 |
Other (Not Including Serious) Adverse Events |
||||
| Teriparatide | Risedronate | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 22/45 (48.9%) | 30/47 (63.8%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain upper | 0/45 (0%) | 0 | 2/47 (4.3%) | 2 |
| Constipation | 1/45 (2.2%) | 1 | 2/47 (4.3%) | 2 |
| Nausea | 1/45 (2.2%) | 1 | 3/47 (6.4%) | 3 |
| Reflux oesophagitis | 1/45 (2.2%) | 1 | 2/47 (4.3%) | 2 |
| General disorders | ||||
| Oedema peripheral | 3/45 (6.7%) | 4 | 2/47 (4.3%) | 2 |
| Hepatobiliary disorders | ||||
| Cholelithiasis | 2/45 (4.4%) | 2 | 0/47 (0%) | 0 |
| Infections and infestations | ||||
| Influenza | 4/45 (8.9%) | 4 | 3/47 (6.4%) | 4 |
| Lung infection | 0/45 (0%) | 0 | 2/47 (4.3%) | 2 |
| Nasopharyngitis | 2/45 (4.4%) | 2 | 2/47 (4.3%) | 2 |
| Injury, poisoning and procedural complications | ||||
| Rib fracture | 0/45 (0%) | 0 | 2/47 (4.3%) | 4 |
| Investigations | ||||
| Blood cholesterol increased | 0/45 (0%) | 0 | 2/47 (4.3%) | 2 |
| Weight decreased | 0/45 (0%) | 0 | 2/47 (4.3%) | 2 |
| Weight increased | 1/45 (2.2%) | 1 | 3/47 (6.4%) | 3 |
| Metabolism and nutrition disorders | ||||
| Obesity | 2/45 (4.4%) | 2 | 0/47 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 4/45 (8.9%) | 4 | 3/47 (6.4%) | 4 |
| Back pain | 3/45 (6.7%) | 3 | 0/47 (0%) | 0 |
| Pain in extremity | 1/45 (2.2%) | 1 | 2/47 (4.3%) | 2 |
| Nervous system disorders | ||||
| Headache | 1/45 (2.2%) | 1 | 2/47 (4.3%) | 3 |
| Paraesthesia | 2/45 (4.4%) | 2 | 0/47 (0%) | 0 |
| Psychiatric disorders | ||||
| Insomnia | 2/45 (4.4%) | 2 | 0/47 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnoea | 0/45 (0%) | 0 | 3/47 (6.4%) | 3 |
| Skin and subcutaneous tissue disorders | ||||
| Erythema | 2/45 (4.4%) | 2 | 0/47 (0%) | 0 |
| Urticaria | 0/45 (0%) | 0 | 2/47 (4.3%) | 2 |
| Surgical and medical procedures | ||||
| Cataract operation | 2/45 (4.4%) | 2 | 1/47 (2.1%) | 2 |
| Vascular disorders | ||||
| Haematoma | 0/45 (0%) | 0 | 2/47 (4.3%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Eli Lilly and Company |
| Phone | 800-545-5979 |
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