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NCT01631214 · ClinicalTrials.gov registry record · Phase 3
Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,093
- Enrollment target
NCT01631214: Completed Phase 3 study, sponsored by Amgen.
NCT01631214 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 4,093 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (430% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01631214, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,093 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.
Primary Outcome
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,
Interventions
- DRUG Alendronate
- BIOLOGICAL Romosozumab
- DRUG Placebo to Romosozumab
- DRUG Placebo to Alendronate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,093 participants |
| Start Date | 2012-05-04 |
| Est. Completion | 2017-06-29 |
| Phase | Phase 3 |
What the finished NCT01631214 record still lists
NCT01631214 is an interventional study that assigns participants to a tested intervention. Its 4,093 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (430% higher).
The record links to 0 conditions, and to 4 interventions - of which Alendronate is the first listed.
NCT01631214 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01631214 about?
NCT01631214 is a clinical study titled "Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis". The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.
What is the current status of trial NCT01631214?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,093 participants. The study started on 2012-05-04. Estimated completion is 2017-06-29.
What interventions are being tested in trial NCT01631214?
The interventions under investigation include: Alendronate (DRUG), Romosozumab (BIOLOGICAL), Placebo to Romosozumab (DRUG), Placebo to Alendronate (DRUG).
Who is sponsoring clinical trial NCT01631214?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01631214's enrollment target sits among peer trials
4,093 61st of 2000 higher than 1,940 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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