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NCT03432533 · ClinicalTrials.gov registry record · Phase 3
A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 283
- Enrollment target
NCT03432533: Completed Phase 3 study, sponsored by Amgen.
NCT03432533 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 283 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03432533, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 283 participants
- Enrollment target
Study Summary
To evaluate the noninferiority of a 6-month treatment with 210 mg romosozumab at 90 mg/mL administered subcutaneously (SC) once a month (QM) in postmenopausal women with osteoporosis either by healthcare provider (HCP) administration with prefilled syringe (PFS) or by subject self-administration with autoinjector/pen (AI/Pen)
Primary Outcome
Percent change from baseline in BMD at the lumbar spine as measured by dual-energy x-ray absorptiometry (DXA).
Interventions
- DRUG romosozumab HCP administration with PFS
- DEVICE romosozumab self-administration with AI/Pen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 283 participants |
| Start Date | 2018-02-06 |
| Est. Completion | 2020-01-08 |
| Phase | Phase 3 |
What the finished NCT03432533 record still lists
NCT03432533 is an interventional study that assigns participants to a tested intervention. The registered 283 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 (63% lower).
The record links to 0 conditions, and to 2 interventions - of which romosozumab HCP administration with PFS is the first listed.
NCT03432533 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03432533 about?
NCT03432533 is a clinical study titled "A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis". To evaluate the noninferiority of a 6-month treatment with 210 mg romosozumab at 90 mg/mL administered subcutaneously (SC) once a month (QM) in postmenopausal women with osteoporosis either by healthcare provider (HCP) administration with prefilled syringe (PFS) or by subject self-administration wit...
What is the current status of trial NCT03432533?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 283 participants. The study started on 2018-02-06. Estimated completion is 2020-01-08.
What interventions are being tested in trial NCT03432533?
The interventions under investigation include: romosozumab HCP administration with PFS (DRUG), romosozumab self-administration with AI/Pen (DEVICE).
Who is sponsoring clinical trial NCT03432533?
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 NCT03432533's enrollment target sits among peer trials
283 1194th of 2000 higher than 807 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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