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
Amgen
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.
Eligibility
- Age range
- 5–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures. OR * Participant's legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent and the participant has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated. * Ambulatory male and female children and adolescents, age 5 to \<18 years, including ambulatory with assistance as defined in the pediatric osteoge…
Interventions
- DrugRomosozumab
Subcutaneous (SC) injection
- DrugBisphosphonate
Administration determined by investigator according to the local standard of care
Locations (65)
- Childrens Hospital of AlabamaBirmingham, Alabama
- Phoenix Childrens HospitalPhoenix, Arizona
- University of California, Los Angeles Interventional Clinical TrialsLos Angeles, California
- Nemours Hospital for ChildrenWilmington, Delaware
- Nemours Childrens HospitalOrlando, Florida
- University of South Florida - Carol and Frank Morsani Center for Advanced Health CareTampa, Florida