Osteogenesis Imperfecta Clinical Trials

Find Osteogenesis Imperfecta Clinical Trials Near You

Multicenter, Safety Follow-up Study to Assess Safety of Prior Treatment With Romosozumab in Children and Adolescents With Osteogenesis Imperfecta

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 19
Healthy Volunteers: f
View:

• \- 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 investigational product (romosozumab) until the last protocol-specified dose or ended investigational product early.

Locations
United States
Indiana
Indiana University
RECRUITING
Indianapolis
Other Locations
Germany
Universitaetsklinikum Wuerzburg
RECRUITING
Würzburg
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2026-03-18
Estimated Completion Date: 2028-05-21
Participants
Target number of participants: 71
Treatments
Other: Standard of Care
Participants who completed romosozumab trial 20200105 will continue to receive standard of care treatment (calcium and vitamin D), as determined by the investigator and local guidance. No investigational drug product will be administered in this trial as this is a safety follow-up.
Related Therapeutic Areas
Sponsors
Leads: Amgen

This content was sourced from clinicaltrials.gov