Trial · NCT01631214
Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
NCT01631214, Phase 3, Completed, Amgen; results first posted 2018-12-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis. Trials, record NCT01631214. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01631214
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
- NCT number
- NCT01631214
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,093 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Postmenopausal Women With Osteoporosis
- Interventions
- Romosozumab, Alendronate, Placebo to Romosozumab, Placebo to Alendronate
- First posted
- 2012-06-29
- Last updated
- 2025-02-21
- Other registries' IDs
- eudract:2011-003142-41
- Results first posted
- 2018-12-12
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With New Vertebral Fractures Through Month 24 | 24 months | All fracture assessments were performed by blinded central imaging readers. New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant Semiquantitative Scoring method based on assessment of x-rays according to the following scale: * Grade 0 (Normal) = no fracture; * Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior); * Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height; * Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height. Incident vertebral fractures were confirmed by a second independent reader using the Semiquantitative method. |
| Primary | Percentage of Participants With a Clinical Fracture at the Primary Analysis | The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3). | All fracture assessments were performed by blinded central imaging readers. Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded. |
| Secondary | Percentage of Participants With a Nonvertebral Fracture at the Primary Analysis | The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3). | A nonvertebral fracture was defined as a documented fracture excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded. |
| Secondary | Percentage of Participants With Any Fracture at the Primary Analysis | The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3). | All fractures include any osteoporotic nonvertebral fractures that are not associated with high trauma severity or pathologic fractures and new or worsening vertebral fractures regardless of trauma severity or pathologic fractures. |
| Secondary | Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24 | 24 months | A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4 according to the Genant Semiquantitative Scoring method based on assessment of x-rays according to the following scale: * Grade 0 (Normal) = no fracture; * Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior); * Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height; * Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height. Incident vertebral fractures were confirmed by a second independent reader using the Semiquantitative method. |
| Secondary | Percentage of Participants With a Major Nonvertebral Fracture at the Primary Analysis | The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3). | Major nonvertebral fractures included a subset of nonvertebral fractures including pelvis, distal femur (ie, femur excluding hip), proximal tibia (ie, tibia excluding ankle), ribs, proximal humerus (ie, humerus excluding elbow), forearm, and hip. |
| Secondary | Percentage of Participants With a Hip Fracture at the Primary Analysis | The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3). | Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter. |
| Secondary | Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 24 | 24 months | A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4 according to the Genant Semiquantitative Scoring method. A participant had multiple new or worsening vertebral fractures when there were ≥ 2 vertebrae from T4 to L4 with ≥ 1 grade increase from the previous grade. The multiple new or worsening vertebral fractures need not have occurred at the same visit. Incident vertebral fractures were confirmed by a second independent reader. |
| Secondary | Percentage of Participants With a Clinical Fracture Through Month 24 | 24 months | Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded. |
| Secondary | Percentage of Participants With a Nonvertebral Fracture Through Month 24 | 24 months | A nonvertebral fracture was defined as a documented fracture excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With New Vertebral Fractures Through Month 24 | 24 months | Randomized participants with a baseline and ≥ 1 postbaseline evaluation of vertebral fracture, including participants who had vertebrae with missing Genant semiquantitative scores at baseline whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. Last observation carried forward imputation was used. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With a Clinical Fracture at the Primary Analysis | The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3). | All randomized participants. Missing values for clinical fractures were imputed using last observation carried forward. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Nonvertebral Fracture at the Primary Analysis | The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3). | All randomized participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Any Fracture at the Primary Analysis | The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3). | All randomized participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24 | 24 months | Randomized participants with a baseline and ≥ 1 postbaseline evaluation of vertebral fracture, including participants who had vertebrae with missing Genant semiquantitative scores at baseline whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. Last observation carried forward imputation was used. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Major Nonvertebral Fracture at the Primary Analysis | The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3). | All randomized participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Hip Fracture at the Primary Analysis | The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3). | All randomized participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 24 | 24 months | Randomized participants with a baseline and ≥ 1 postbaseline evaluation of vertebral fracture, including participants who had vertebrae with missing Genant semiquantitative scores at baseline whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. Last observation carried forward imputation was used. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Clinical Fracture Through Month 24 | 24 months | All randomized participants; Missing values for clinical fractures were imputed using last observation carried forward. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Nonvertebral Fracture Through Month 24 | 24 months | All randomized participants | percentage of participants | NUMBER |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With New Vertebral Fractures Through Month 24 | Alendronate/Alendronate | 8.0 | percentage of participants | ||
| Percentage of Participants With New Vertebral Fractures Through Month 24 | Romosozumab/Alendronate | 4.1 | percentage of participants | ||
| Percentage of Participants With a Clinical Fracture at the Primary Analysis | Alendronate/Alendronate | 13.0 | percentage of participants | ||
| Percentage of Participants With a Clinical Fracture at the Primary Analysis | Romosozumab/Alendronate | 9.7 | percentage of participants | ||
| Percentage of Participants With a Nonvertebral Fracture at the Primary Analysis | Alendronate/Alendronate | 10.6 | percentage of participants | ||
| Percentage of Participants With a Nonvertebral Fracture at the Primary Analysis | Romosozumab/Alendronate | 8.7 | percentage of participants | ||
| Percentage of Participants With Any Fracture at the Primary Analysis | Alendronate/Alendronate | 19.1 | percentage of participants | ||
| Percentage of Participants With Any Fracture at the Primary Analysis | Romosozumab/Alendronate | 13.0 | percentage of participants | ||
| Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24 | Alendronate/Alendronate | 9.2 | percentage of participants | ||
| Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24 | Romosozumab/Alendronate | 4.8 | percentage of participants |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Alendronate/Alendronate | 2,047 | |
| Overall Study | STARTED | Romosozumab/Alendronate | 2,046 | |
| Overall Study | Received Double-blind Treatment | Alendronate/Alendronate | 2,040 | |
| Overall Study | Received Double-blind Treatment | Romosozumab/Alendronate | 2,038 | |
| Overall Study | Completed Double-blind Period | Alendronate/Alendronate | 1,823 | |
| Overall Study | Completed Double-blind Period | Romosozumab/Alendronate | 1,831 | |
| Overall Study | Completed Primary Analysis Period | Alendronate/Alendronate | 1,576 | |
| Overall Study | Completed Primary Analysis Period | Romosozumab/Alendronate | 1,574 | |
| Overall Study | COMPLETED | Alendronate/Alendronate | 1,503 | |
| Overall Study | COMPLETED | Romosozumab/Alendronate | 1,523 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events2,692
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 | Double-blind Period: Alendronate 70 mg QW | 49 | 2,014 | |
| other | Anaemia | Blood and lymphatic system disorders | Double-blind Period: Romosozumab 210 mg QM | 41 | 2,040 | |
| other | Anaemia | Blood and lymphatic system disorders | Overall Study: Alendronate / Alendronate | 113 | 2,014 | |
| other | Anaemia | Blood and lymphatic system disorders | Overall Study: Romosozumab / Alendronate | 84 | 2,040 | |
| other | Cataract | Eye disorders | Double-blind Period: Alendronate 70 mg QW | 32 | 2,014 | |
| other | Cataract | Eye disorders | Double-blind Period: Romosozumab 210 mg QM | 46 | 2,040 | |
| other | Cataract | Eye disorders | Overall Study: Alendronate / Alendronate | 97 | 2,014 | |
| other | Cataract | Eye disorders | Overall Study: Romosozumab / Alendronate | 105 | 2,040 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Double-blind Period: Alendronate 70 mg QW | 63 | 2,014 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Double-blind Period: Romosozumab 210 mg QM | 62 | 2,040 |
1 to 10 of 2,692Source ClinicalTrials.gov
See all 2,692 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double-blind Period: Alendronate 70 mg QW | 22 | 2,014 |
| Total, all-cause mortality | Double-blind Period: Romosozumab 210 mg QM | 30 | 2,040 |
| Total, all-cause mortality | Overall Study: Alendronate / Alendronate | 103 | 2,014 |
| Total, all-cause mortality | Overall Study: Romosozumab / Alendronate | 101 | 2,040 |
| Total, other adverse events | Double-blind Period: Alendronate 70 mg QW | 1,190 | 2,014 |
| Total, other adverse events | Double-blind Period: Romosozumab 210 mg QM | 1,112 | 2,040 |
| Total, other adverse events | Overall Study: Alendronate / Alendronate | 1,498 | 2,014 |
| Total, other adverse events | Overall Study: Romosozumab / Alendronate | 1,424 | 2,040 |
| Total, serious adverse events | Double-blind Period: Alendronate 70 mg QW | 278 | 2,014 |
| Total, serious adverse events | Double-blind Period: Romosozumab 210 mg QM | 262 | 2,040 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers8
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/NCT01631214
GET https://conductscience.org/api/trials/v1/NCT01631214/registered?page=2