Trials / Recruiting
RecruitingNCT05972551
Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
A Phase 3, Open-Label, Multicenter, Randomized Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 106 (estimated)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 5 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the effect of romosozumab treatment for 12-months compared with bisphosphonate(s) on the number of clinical fractures at 12-months; the number of any fractures at 12-months and change in lumbar spine bone mineral density (BMD) Z-score at 6-months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Romosozumab | Subcutaneous (SC) injection |
| DRUG | Bisphosphonate | Administration determined by investigator according to the local standard of care |
Timeline
- Start date
- 2024-04-22
- Primary completion
- 2027-06-01
- Completion
- 2027-08-25
- First posted
- 2023-08-02
- Last updated
- 2026-04-03
Locations
65 sites across 18 countries: United States, Australia, Austria, Belgium, Canada, China, France, Germany, Hungary, Italy, Japan, Poland, Saudi Arabia, Slovakia, Spain, Switzerland, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05972551. Inclusion in this directory is not an endorsement.