Multicenter, Safety Follow-up Study to Assess Safety of Prior Treatment With Romosozumab in Children and Adolescents With Osteogenesis Imperfecta
Amgen
Summary
The primary objective of this trial is to evaluate the safety of romosozumab in participants with osteogenesis imperfecta (OI) that have completed Study 20200105, regardless of whether they received investigational product (romosozumab) until the last protocol-specified dose or ended investigational product early.
Eligibility
- Age range
- 5–19 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: \- Participant has provided informed consent/assent prior to initiation of any trial 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 trial-specific activities/procedures being initiated. \- Participant was randomized to the romosozumab arm and completed Trial 20200105 through the Month 15 Visit, regardless of whether they received in…
Interventions
- Dietary SupplementVitamin D
Participants are recommended to receive Vitamin D supplements as standard of care treatment, per investigator discretion and local guidance.
- Dietary SupplementCalcium
Participants are recommended to receive Calcium supplements as standard of care treatment, per investigator discretion and local guidance.
Locations (4)
- Indiana UniversityIndianapolis, Indiana
- Universitaetsklinikum KoelnCologne
- Universitaetsklinikum WuerzburgWürzburg
- Okayama Saiseikai Outpatient Center HospitalOkayama, Okayama-ken