Trial · NCT01575834
Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
NCT01575834, Phase 3, Completed, Amgen; results first posted 2018-11-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis. Trials, record NCT01575834. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01575834
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
- NCT number
- NCT01575834
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 7,180 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Postmenopausal Osteoporosis
- Interventions
- Romosozumab, Placebo, Denosumab
- First posted
- 2012-04-12
- Last updated
- 2024-08-28
- Other registries' IDs
- eudract:2011-001456-11
- Results first posted
- 2018-11-08
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With New Vertebral Fracture Through Month 12 | 12 Months | 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. The Genant semiquantitative scoring method was 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. |
| Primary | Percentage of Participants With New Vertebral Fracture Through Month 24 | 24 months | 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. The Genant semiquantitative scoring method was 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. |
| Secondary | Percentage of Participants With a Clinical Fracture Through Month 12 | 12 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 12 | 12 Months | A nonvertebral fracture was defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging confirming the fracture within 14 days of reported fracture image date recorded by the study site, and/or documented in a copy of the radiology report, surgical report, or discharge summary, 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 a Nonvertebral Fracture Through Month 24 | 24 Months | A nonvertebral fracture was defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging confirming the fracture within 14 days of reported fracture image date as recorded by the study site, and/or documented in a copy of the radiology report, surgical report, or discharge summary, 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 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 Major Nonvertebral Fracture Through Month 12 | 12 Months | A major nonvertebral fracture was 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 Major Nonvertebral Fracture Through Month 24 | 24 Months | A major nonvertebral fracture was 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 New or Worsening Vertebral Fracture Through Month 12 | 12 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. |
| 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. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
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 Fracture Through Month 12 | 12 Months | Primary efficacy analysis set includes all participants who had a baseline and ≥ 1 postbaseline evaluation of vertebral fracture during the 12 months, including participants with missing baseline Genant scores 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 New Vertebral Fracture Through Month 24 | 24 months | Primary efficacy analysis set includes all participants who had a baseline and ≥ 1 postbaseline evaluation of vertebral fracture during the 24 months, including participants with missing baseline Genant scores 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 12 | 12 Months | Full analysis set; Last observation carried forward imputation (LOCF) was used. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Nonvertebral Fracture Through Month 12 | 12 Months | Full analysis set | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Nonvertebral Fracture Through Month 24 | 24 Months | Full analysis set | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Clinical Fracture Through Month 24 | 24 Months | Full analysis set; LOCF imputation was used | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Major Nonvertebral Fracture Through Month 12 | 12 Months | Full analysis set | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Major Nonvertebral Fracture Through Month 24 | 24 Months | Full analysis set | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 12 | 12 Months | Primary efficacy analysis set includes all participants who had a baseline and ≥ 1 postbaseline evaluation of vertebral fracture during the 24 months, including participants with missing baseline Genant scores whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. LOCF imputation was used | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24 | 24 Months | Primary efficacy analysis set includes all participants who had a baseline and ≥ 1 postbaseline evaluation of vertebral fracture during the 24 months, including participants with missing baseline Genant scores whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. LOCF imputation was used. | percentage of participants | NUMBER |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group44
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 Fracture Through Month 12 | Placebo | 1.8 | percentage of participants | ||
| Percentage of Participants With New Vertebral Fracture Through Month 12 | Romosozumab | 0.5 | percentage of participants | ||
| Percentage of Participants With New Vertebral Fracture Through Month 24 | Placebo/Denosumab | 2.5 | percentage of participants | ||
| Percentage of Participants With New Vertebral Fracture Through Month 24 | Romosozumab/Denosumab | 0.6 | percentage of participants | ||
| Percentage of Participants With a Clinical Fracture Through Month 12 | Placebo | 2.5 | percentage of participants | ||
| Percentage of Participants With a Clinical Fracture Through Month 12 | Romosozumab | 1.6 | percentage of participants | ||
| Percentage of Participants With a Nonvertebral Fracture Through Month 12 | Placebo | 2.1 | percentage of participants | ||
| Percentage of Participants With a Nonvertebral Fracture Through Month 12 | Romosozumab | 1.6 | percentage of participants | ||
| Percentage of Participants With a Nonvertebral Fracture Through Month 24 | Placebo/Denosumab | 3.6 | percentage of participants | ||
| Percentage of Participants With a Nonvertebral Fracture Through Month 24 | Romosozumab/Denosumab | 2.7 | percentage of participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo/Denosumab | 3,591 | |
| Overall Study | STARTED | Romosozumab/Denosumab | 3,589 | |
| Overall Study | Received Double-blind Treatment | Placebo/Denosumab | 3,582 | |
| Overall Study | Received Double-blind Treatment | Romosozumab/Denosumab | 3,575 | |
| Overall Study | Completed Double-blind Period | Placebo/Denosumab | 3,205 | |
| Overall Study | Completed Double-blind Period | Romosozumab/Denosumab | 3,185 | |
| Overall Study | Completed 24-month Study Period | Placebo/Denosumab | 3,032 | |
| Overall Study | Completed 24-month Study Period | Romosozumab/Denosumab | 2,994 | |
| Overall Study | COMPLETED | Placebo/Denosumab | 2,892 | |
| Overall Study | COMPLETED | Romosozumab/Denosumab | 2,851 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events3,056
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 | Constipation | Gastrointestinal disorders | 12-Month Double-blind Period: Placebo | 162 | 3,576 | |
| other | Constipation | Gastrointestinal disorders | 12-Month Double-blind Period: Romosozumab | 138 | 3,581 | |
| other | Constipation | Gastrointestinal disorders | 36-Month Study Period: Placebo/Denosumab | 210 | 3,576 | |
| other | Constipation | Gastrointestinal disorders | 36-Month Study Period: Romosozumab/Denosumab | 189 | 3,581 | |
| other | Diarrhoea | Gastrointestinal disorders | 12-Month Double-blind Period: Placebo | 133 | 3,576 | |
| other | Diarrhoea | Gastrointestinal disorders | 12-Month Double-blind Period: Romosozumab | 111 | 3,581 | |
| other | Diarrhoea | Gastrointestinal disorders | 36-Month Study Period: Placebo/Denosumab | 191 | 3,576 | |
| other | Diarrhoea | Gastrointestinal disorders | 36-Month Study Period: Romosozumab/Denosumab | 182 | 3,581 | |
| other | Influenza | Infections and infestations | 12-Month Double-blind Period: Placebo | 180 | 3,576 | |
| other | Influenza | Infections and infestations | 12-Month Double-blind Period: Romosozumab | 169 | 3,581 |
1 to 10 of 3,056Source ClinicalTrials.gov
See all 3,056 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 12-Month Double-blind Period: Placebo | ||
| Total, all-cause mortality | 12-Month Double-blind Period: Romosozumab | ||
| Total, all-cause mortality | 36-Month Study Period: Placebo/Denosumab | ||
| Total, all-cause mortality | 36-Month Study Period: Romosozumab/Denosumab | ||
| Total, other adverse events | 12-Month Double-blind Period: Placebo | 2,059 | 3,576 |
| Total, other adverse events | 12-Month Double-blind Period: Romosozumab | 2,019 | 3,581 |
| Total, other adverse events | 36-Month Study Period: Placebo/Denosumab | 2,434 | 3,576 |
| Total, other adverse events | 36-Month Study Period: Romosozumab/Denosumab | 2,463 | 3,581 |
| Total, serious adverse events | 12-Month Double-blind Period: Placebo | 314 | 3,576 |
| Total, serious adverse events | 12-Month Double-blind Period: Romosozumab | 344 | 3,581 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers17
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.
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