Trial · NCT01796301
An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women
NCT01796301, Phase 3, Completed, Amgen; results first posted 2018-11-08
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women. Trials, record NCT01796301. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01796301
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women
- NCT number
- NCT01796301
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 436 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Postmenopausal Osteoporosis
- Interventions
- Romozosumab, Teriparatide
- First posted
- 2013-02-21
- Last updated
- 2022-11-29
- Other registries' IDs
- eudract:2012-002948-24
- Results first posted
- 2018-11-08
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD) | Baseline, month 6 and month 12 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). Percent change from baseline through month 12 is the average of the treatment effect at months 6 and 12. |
| Secondary | Percent Change From Baseline in Total Hip BMD at Month 6 | Baseline and month 6 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). |
| Secondary | Percent Change From Baseline in Total Hip BMD at Month 12 | Baseline and month 12 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). |
| Secondary | Percent Change From Baseline in Cortical BMD by Quantitative Computed Tomography (QCT) at the Total Hip at Month 6 | Baseline and month 6 | Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip. |
| Secondary | Percent Change From Baseline in Cortical BMD by QCT at the Total Hip at Month 12 | Baseline and month 12 | Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip. |
| Secondary | Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 6 | Baseline and month 6 | Integral BMD was measured by quantitative computed tomography (QCT) at the total hip. |
| Secondary | Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 12 | Baseline and month 12 | Integral BMD was measured by quantitative computed tomography (QCT) at the total hip. |
| Secondary | Percent Change From Baseline in Estimated Strength at the Total Hip at Month 6 | Baseline and month 6 | Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans. |
| Secondary | Percent Change From Baseline in Estimated Strength at the Total Hip at Month 12 | Baseline and month 12 | Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans. |
| Secondary | Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 6 | Baseline and month 6 | Total hip integral BMC was measured using quantitative computed tomography (QCT). |
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 | Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD) | Baseline, month 6 and month 12 | The primary efficacy analysis set includes randomized participants with a non-missing baseline and at least one post-baseline measurement. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Hip BMD at Month 6 | Baseline and month 6 | The primary efficacy analysis set with values at baseline and month 6 | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Hip BMD at Month 12 | Baseline and month 12 | The primary efficacy analysis set with values at baseline and month 12 | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Cortical BMD by Quantitative Computed Tomography (QCT) at the Total Hip at Month 6 | Baseline and month 6 | The primary efficacy analysis set with values at baseline and month 6 | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Cortical BMD by QCT at the Total Hip at Month 12 | Baseline and month 12 | The primary efficacy analysis set with values at baseline and month 12 | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 6 | Baseline and month 6 | The primary efficacy analysis set with values at baseline and month 6 | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 12 | Baseline and month 12 | The primary efficacy analysis set with values at baseline and month 12 | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Estimated Strength at the Total Hip at Month 6 | Baseline and month 6 | The primary efficacy analysis set with values at baseline and month 6 | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Estimated Strength at the Total Hip at Month 12 | Baseline and month 12 | The primary efficacy analysis set with values at baseline and month 12 | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 6 | Baseline and month 6 | The primary efficacy analysis set with values at baseline and month 6 | percent change | LEAST_SQUARES_MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD) | Teriparatide | -0.6 | Standard Error 0.2 | percent change | |
| Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD) | Romosozumab | 2.6 | Standard Error 0.2 | percent change | |
| Percent Change From Baseline in Total Hip BMD at Month 6 | Teriparatide | -0.8 | Standard Error 0.2 | percent change | |
| Percent Change From Baseline in Total Hip BMD at Month 6 | Romosozumab | 2.3 | Standard Error 0.2 | percent change | |
| Percent Change From Baseline in Total Hip BMD at Month 12 | Teriparatide | -0.5 | Standard Error 0.2 | percent change | |
| Percent Change From Baseline in Total Hip BMD at Month 12 | Romosozumab | 2.9 | Standard Error 0.2 | percent change | |
| Percent Change From Baseline in Cortical BMD by Quantitative Computed Tomography (QCT) at the Total Hip at Month 6 | Teriparatide | -2.7 | Standard Error 0.2 | percent change | |
| Percent Change From Baseline in Cortical BMD by Quantitative Computed Tomography (QCT) at the Total Hip at Month 6 | Romosozumab | 0.7 | Standard Error 0.2 | percent change | |
| Percent Change From Baseline in Cortical BMD by QCT at the Total Hip at Month 12 | Teriparatide | -3.6 | Standard Error 0.3 | percent change | |
| Percent Change From Baseline in Cortical BMD by QCT at the Total Hip at Month 12 | Romosozumab | 1.1 | Standard Error 0.3 | percent change |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Teriparatide | 218 | |
| Overall Study | STARTED | Romosozumab | 218 | |
| Overall Study | Received Treatment | Teriparatide | 214 | |
| Overall Study | Received Treatment | Romosozumab | 218 | |
| Overall Study | COMPLETED | Teriparatide | 200 | |
| Overall Study | COMPLETED | Romosozumab | 198 | |
| Overall Study | NOT COMPLETED | Teriparatide | 18 | |
| Overall Study | NOT COMPLETED | Romosozumab | 20 |
Source ClinicalTrials.gov
Adverse events132
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 | Nasopharyngitis | Infections and infestations | Teriparatide | 22 | 214 | |
| other | Nasopharyngitis | Infections and infestations | Romosozumab | 28 | 218 | |
| other | Upper respiratory tract infection | Infections and infestations | Teriparatide | 9 | 214 | |
| other | Upper respiratory tract infection | Infections and infestations | Romosozumab | 11 | 218 | |
| other | Fall | Injury, poisoning and procedural complications | Teriparatide | 5 | 214 | |
| other | Fall | Injury, poisoning and procedural complications | Romosozumab | 12 | 218 | |
| other | Hypercalcaemia | Metabolism and nutrition disorders | Teriparatide | 22 | 214 | |
| other | Hypercalcaemia | Metabolism and nutrition disorders | Romosozumab | 2 | 218 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Teriparatide | 13 | 214 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Romosozumab | 22 | 218 |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 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 | Romosozumab | ||
| Total, other adverse events | Teriparatide | 76 | 214 |
| Total, other adverse events | Romosozumab | 79 | 218 |
| Total, serious adverse events | Teriparatide | 23 | 214 |
| Total, serious adverse events | Romosozumab | 17 | 218 |
Source ClinicalTrials.gov
Papers2
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Teriparatide vs Romosozumab: serious adverse events |
Source Trial comparisons
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/NCT01796301
GET https://conductscience.org/api/trials/v1/NCT01796301/results?page=2