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NCT01575834 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 7,180
- Enrollment target
NCT01575834: Completed Phase 3 study, sponsored by Amgen.
NCT01575834 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 7,180 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (830% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01575834, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 7,180 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis
Primary Outcome
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 ante
Interventions
- DRUG Placebo
- DRUG Romosozumab
- DRUG Denosumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7,180 participants |
| Start Date | 2012-03-15 |
| Est. Completion | 2016-12-28 |
| Phase | Phase 3 |
What the finished NCT01575834 record still lists
NCT01575834 is an interventional study that assigns participants to a tested intervention. Its 7,180 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 (830% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01575834 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01575834 about?
NCT01575834 is a clinical study titled "Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis". The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis
What is the current status of trial NCT01575834?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 7,180 participants. The study started on 2012-03-15. Estimated completion is 2016-12-28.
What interventions are being tested in trial NCT01575834?
The interventions under investigation include: Placebo (DRUG), Romosozumab (DRUG), Denosumab (DRUG).
Who is sponsoring clinical trial NCT01575834?
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 NCT01575834's enrollment target sits among peer trials
7,180 34th of 2000 higher than 1,967 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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