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NCT02016716 · ClinicalTrials.gov registry record · Phase 3
A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 294
- Enrollment target
NCT02016716: Completed Phase 3 study, sponsored by Amgen.
NCT02016716 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 294 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02016716, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 294 participants
- Enrollment target
Study Summary
The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone mineral density (BMD) in postmenopausal women with osteoporosis.
Primary Outcome
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
Interventions
- DRUG Romosozumab 90 mg/mL
- DRUG Placebo 90 mg/mL
- DRUG Romosozumab 70 mg/mL
- DRUG Placebo 70 mg/mL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 294 participants |
| Start Date | 2013-12-03 |
| Est. Completion | 2014-12-08 |
| Phase | Phase 3 |
What the finished NCT02016716 record still lists
NCT02016716 is an interventional study that assigns participants to a tested intervention. The registered 294 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 4 interventions - of which Romosozumab 90 mg/mL is the first listed.
NCT02016716 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02016716 about?
NCT02016716 is a clinical study titled "A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis". The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone mineral density (BMD) in postmenopausal women with osteoporosis.
What is the current status of trial NCT02016716?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 294 participants. The study started on 2013-12-03. Estimated completion is 2014-12-08.
What interventions are being tested in trial NCT02016716?
The interventions under investigation include: Romosozumab 90 mg/mL (DRUG), Placebo 90 mg/mL (DRUG), Romosozumab 70 mg/mL (DRUG), Placebo 70 mg/mL (DRUG).
Who is sponsoring clinical trial NCT02016716?
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 NCT02016716's enrollment target sits among peer trials
294 1166th of 2000 higher than 835 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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