clinical trial · NCT05972551
Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
Amgen·phase3·recruiting·n = 106
Osteogenesis ImperfectaRomosozumabBisphosphonate
brief 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.
started
Apr 22, 2024
primary completion
Jun 1, 2027
completion
Aug 25, 2027
last updated
Apr 3, 2026
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol