Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
← catalyst calendarNCT05972551 · readout in 258 d
Sponsored by Amgen (industry) · AMGN — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
111actual
Sites
65
Countries
Australia, Austria, Belgium +15
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-04-22 | actual | When the study began enrolling |
| Primary completion | 2027-05-04 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-07-30 | estimated | The whole study's end, after follow-up |
| First posted | 2023-08-02 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-27 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Osteogenesis Imperfecta
Interventions
- Drug: Romosozumab — also filed as EVENITY®
- Drug: Bisphosphonate
Primary outcomes
what the primary-completion date above is the date OFNumber of Clinical Fractures
measured 12 months
Number of Any Fractures
measured 12 months
Change from Baseline in Lumbar Spine BMD Z-score at 12 Months, as assessed by DXA
measured Baseline and 12 months
Publications
- PMID 42470570 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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