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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 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 4,093 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01631214
The ClinicalTrials.gov registry entry for NCT01631214 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4,093 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Alendronate is the first listed.
NCT01631214 reports 0 study locations.
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.
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