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NCT05972551 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
A Phase 3 study of Osteogenesis Imperfecta, sponsored by Amgen.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 106
- Enrollment target
- 20
- Study locations
NCT05972551: Recruiting Phase 3 study of Osteogenesis Imperfecta, sponsored by Amgen.
NCT05972551 is a Phase 3 study of Osteogenesis Imperfecta that is actively recruiting participants, run by Amgen. The registered enrollment target is 106 participants, below the 153-participant average among 13 other Osteogenesis Imperfecta trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05972551, a Phase 3 study of Osteogenesis Imperfecta, is actively recruiting participants, sponsored by Amgen.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 106 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Clinical fractures include clinical vertebral fractures and nonvertebral fractures.
Conditions Studied
Interventions
- DRUG Bisphosphonate
- DRUG Romosozumab
Study Locations (20)
Florida
- Nemours Childrens Hospital - Orlando
- University of South Florida - Carol and Frank Morsani Center for Advanced Health Care - Tampa
Minnesota
- Mayo Clinic Childrens Center - Rochester
- Gillette Childrens Hospital and Clinic Saint Paul - Saint Paul
Other
- Kepler Universitaetsklinikum GmbH - Linz
- Universitair Ziekenhuis Leuven - Campus Gasthuisberg - Leuven
Ontario
- Childrens Hospital of Eastern Ontario - Ottawa
- The Hospital for Sick Children - Toronto
Alabama
- Childrens Hospital of Alabama - Birmingham
Arizona
- Phoenix Childrens Hospital - Phoenix
California
- University of California, Los Angeles Interventional Clinical Trials - Los Angeles
Delaware
- Nemours Hospital for Children - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2024-04-22 |
| Est. Completion | 2027-08-25 |
| Phase | Phase 3 |
What NCT05972551 shows while recruiting
NCT05972551 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 153-participant average among 13 other Osteogenesis Imperfecta trials with a reported enrollment target (31% lower).
The record links to 1 condition, with Osteogenesis Imperfecta appearing as the primary indexed condition, and to 2 interventions - of which Bisphosphonate is the first listed.
NCT05972551 names 20 study sites across 16 states, led by Florida, Minnesota, Other.
Frequently Asked Questions
What is clinical trial NCT05972551 about?
NCT05972551 is a clinical study titled "Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta". 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.
What is the current status of trial NCT05972551?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 106 participants. The study started on 2024-04-22. Estimated completion is 2027-08-25.
What conditions does trial NCT05972551 study?
This clinical trial studies the following conditions: Osteogenesis Imperfecta.
What interventions are being tested in trial NCT05972551?
The interventions under investigation include: Bisphosphonate (DRUG), Romosozumab (DRUG).
Who is sponsoring clinical trial NCT05972551?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05972551 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteogenesis Imperfecta
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05972551's enrollment target sits among peer trials
106 5th of 13 higher than 9 of 13 other Osteogenesis Imperfecta trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteogenesis Imperfecta 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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Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta
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BBD Longitudinal Study of Osteogenesis Imperfecta
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