drugset / Trial / NCT05972551
Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-04-22
- Primary completion
- 2027-05-04
- Completion
- 2027-07-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Romosozumab | Monoclonal antibody | — | Subcutaneous |