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
Latest Information Update: 15 Mar 2025
At a glance
- Drugs Romosozumab (Primary) ; Bisphosphonates
- Indications Osteogenesis imperfecta
- Focus Registrational; Therapeutic Use
- Sponsors Amgen
Most Recent Events
- 18 Nov 2024 The protocol has been amended to change in time frame for Primary Outcome Measures Change from Baseline to 12 Months in Lumbar Spine BMD Z-score.
- 30 Apr 2024 Planned End Date changed from 10 Sep 2027 to 6 Sep 2027.
- 30 Apr 2024 Planned primary completion date changed from 7 Jun 2027 to 3 Jun 2027.