Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
Public ClinicalTrials.gov record NCT05972551. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05972551
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 111 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 5 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 22, 2024 (Actual)
- Primary completion
- May 4, 2027 (Estimated)
- Completion
- Jul 30, 2027 (Estimated)
- Last update posted
- May 27, 2026
2024 – 2027
United States locations
- U.S. sites
- 14
- U.S. states
- 12
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Childrens Hospital of Alabama | Birmingham | Alabama | 35233 | — |
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | — |
| University of California, Los Angeles Interventional Clinical Trials | Los Angeles | California | 90095 | — |
| Nemours Hospital for Children | Wilmington | Delaware | 19803 | — |
| Nemours Childrens Hospital | Orlando | Florida | 32827 | — |
| University of South Florida - Carol and Frank Morsani Center for Advanced Health Care | Tampa | Florida | 33606 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Kennedy Krieger Institute | Baltimore | Maryland | 21287 | — |
| Boston Childrens Hospital | Boston | Massachusetts | 02115 | — |
| Mayo Clinic Childrens Center | Rochester | Minnesota | 55905 | — |
| Gillette Childrens Hospital and Clinic Saint Paul | Saint Paul | Minnesota | 55101 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212-3157 | — |
| Marshfield Clinic | Marshfield | Wisconsin | 54449 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 51 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05972551, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 27, 2026 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05972551 live on ClinicalTrials.gov.