Trials / Completed
CompletedNCT03432533
A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis
A Randomized, Multicenter, Open-label, Parallel Group Study in Postmenopausal Women With Osteoporosis to Evaluate the Noninferiority of Subject-administered Romosozumab Via Autoinjector/Pen vs Healthcare Provider-administered Romosozumab Via Prefilled Syringe
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 283 (actual)
- Sponsor
- Amgen · Industry
- Sex
- Female
- Age
- 55 Years – 90 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | romosozumab HCP administration with PFS | 210 mg romosozumab SC QM by HCP administration with 2 PFS |
| DEVICE | romosozumab self-administration with AI/Pen | 210 mg romosozumab SC QM by self-administration with 2 AI/Pens |
Timeline
- Start date
- 2018-02-06
- Primary completion
- 2019-04-11
- Completion
- 2020-01-08
- First posted
- 2018-02-14
- Last updated
- 2020-11-23
- Results posted
- 2020-04-10
Locations
46 sites across 3 countries: United States, Poland, United Kingdom
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03432533. Inclusion in this directory is not an endorsement.