Trial · NCT00051558
Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis
NCT00051558, Phase 3, Completed, Eli Lilly and Company; results first posted 2009-02-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis. Trials, record NCT00051558. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00051558
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis
- NCT number
- NCT00051558
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 428 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Osteoporosis
- Interventions
- Teriparatide, Alendronate Sodium, Placebo, Placebo
- First posted
- 2003-01-14
- Last updated
- 2009-03-12
- Results first posted
- 2009-02-13
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD) | 18 month endpoint | change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA) |
| Secondary | Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset | 18 month endpoint | change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA) |
| Secondary | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | 3, 6, 12, 18, 24, 36 months | change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA) |
| Secondary | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset | 3, 6, 12, and 18 months | change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA) |
| Secondary | Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | 24 and 36 months and Endpoint at 36 months | change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA) |
| Secondary | Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | 18, 24, 36 months, and 18 and 36 month endpoints | change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA) |
| Secondary | Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | 18, 24, 36 months, and 18 and 36 month endpoints | change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA) |
| Secondary | Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | 12, 18, 24, and 36 months | change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA) |
| Secondary | Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | 12, 18, 24, and 36 months | change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA) |
| Secondary | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen | 1, 6, 18, and 36 months |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD) | 18 month endpoint | The intention-to-treat analysis was performed using all randomized and treated patients. | grams per square centimeters | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset | 18 month endpoint | The intention-to-treat analysis was performed using all randomized and treated patients (female only subset). | grams per square centimeters | LEAST_SQUARES_MEAN |
| SECONDARY | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | 3, 6, 12, 18, 24, 36 months | The intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed. | grams per square centimeters | LEAST_SQUARES_MEAN |
| SECONDARY | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset | 3, 6, 12, and 18 months | The intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed. | grams per square centimeters | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | 24 and 36 months and Endpoint at 36 months | The intention-to-treat analysis was performed using all randomized and treated patients. For 24 and 36 month time points, no missing data were imputed. However, at the 36 month endpoint, last observation carried forward analysis was applied. | grams per square centimeters | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | 18, 24, 36 months, and 18 and 36 month endpoints | The intention-to-treat analysis was performed using all randomized and treated patients. For 18, 24 and 36 month time points, no missing data were imputed. However at the 36 month endpoint, last observation carried forward analysis was applied. | grams per square centimeters | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | 18, 24, 36 months, and 18 and 36 month endpoints | The intention-to-treat analysis was performed using all randomized and treated patients. For 18, 24 and 36 month time points, no missing data were imputed. However, at 18 and 36 month endpoints, last observation carried forward analyses were applied. | grams per square centimeters | LEAST_SQUARES_MEAN |
| SECONDARY | Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined | 12, 18, 24, and 36 months | The intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed. | grams per square centimeters | LEAST_SQUARES_MEAN |
| SECONDARY | Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined | 12, 18, 24, and 36 months | The intention-to-treat analysis was performed using all randomized and treated patients. No missing data was imputed. | grams per square centimeters | LEAST_SQUARES_MEAN |
| SECONDARY | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen | 1, 6, 18, and 36 months | Subset of patients with measures of biochemical markers | percent | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group122
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD) | Teriparatide | 0.059 | Standard Error 0.006 | grams per square centimeters | |
| Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD) | Alendronate | 0.028 | Standard Error 0.006 | grams per square centimeters | |
| Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset | Teriparatide | 0.056 | Standard Error 0.006 | grams per square centimeters | |
| Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset | Alendronate | 0.023 | Standard Error 0.006 | grams per square centimeters | |
| Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | Teriparatide | Change from baseline at Month 36 (N=123,N=112) | 0.090 | Standard Error 0.006 | grams per square centimeters |
| Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | Alendronate | Change from baseline at Month 36 (N=123,N=112) | 0.044 | Standard Error 0.007 | grams per square centimeters |
| Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | Teriparatide | Change from baseline at Month 24 (N=136,N=131) | 0.081 | Standard Error 0.006 | grams per square centimeters |
| Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | Alendronate | Change from baseline at Month 24 (N=136,N=131) | 0.043 | Standard Error 0.006 | grams per square centimeters |
| Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | Teriparatide | Change from baseline at Month 18 (N=156,N=148) | 0.066 | Standard Error 0.005 | grams per square centimeters |
| Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined | Alendronate | Change from baseline at Month 18 (N=156,N=148) | 0.031 | Standard Error 0.005 | grams per square centimeters |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Teriparatide | 214 | |
| Overall Study | STARTED | Alendronate | 214 | |
| Overall Study | COMPLETED | Teriparatide | 123 | |
| Overall Study | COMPLETED | Alendronate | 118 | |
| Overall Study | NOT COMPLETED | Teriparatide | 91 | |
| Overall Study | NOT COMPLETED | Alendronate | 96 |
Source ClinicalTrials.gov
Adverse events384
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Teriparatide | 10 | 214 | 10 |
| other | Anaemia | Blood and lymphatic system disorders | Alendronate | 16 | 214 | 16 |
| other | Abdominal pain | Gastrointestinal disorders | Teriparatide | 11 | 214 | 12 |
| other | Abdominal pain | Gastrointestinal disorders | Alendronate | 10 | 214 | 12 |
| other | Abdominal pain upper | Gastrointestinal disorders | Teriparatide | 18 | 214 | 19 |
| other | Abdominal pain upper | Gastrointestinal disorders | Alendronate | 16 | 214 | 16 |
| other | Dyspepsia | Gastrointestinal disorders | Teriparatide | 9 | 214 | 9 |
| other | Dyspepsia | Gastrointestinal disorders | Alendronate | 15 | 214 | 16 |
| other | Gastritis | Gastrointestinal disorders | Teriparatide | 15 | 214 | 15 |
| other | Gastritis | Gastrointestinal disorders | Alendronate | 8 | 214 | 8 |
1 to 10 of 384Source ClinicalTrials.gov
See all 384 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Teriparatide | ||
| Total, all-cause mortality | Alendronate | ||
| Total, other adverse events | Teriparatide | 190 | |
| Total, other adverse events | Alendronate | 177 | |
| Total, serious adverse events | Teriparatide | 70 | |
| Total, serious adverse events | Alendronate | 64 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00051558
GET https://conductscience.org/api/trials/v1/NCT00051558/results?page=2