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RECRUITING
NCT07366086
PHASE3

Pediatric Safety Follow-up Study of Prior Treatment With Romosozumab for Osteogenesis Imperfecta

Sponsor: Amgen

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

5 Years - 19 Years

Study Type

INTERVENTIONAL

Enrollment

71

Start Date

2026-03-18

Completion Date

2028-05-21

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Vitamin D

Participants are recommended to receive Vitamin D supplements as standard of care treatment, per investigator discretion and local guidance.

DIETARY_SUPPLEMENT

Calcium

Participants are recommended to receive Calcium supplements as standard of care treatment, per investigator discretion and local guidance.

Locations (2)

Indiana University

Indianapolis, Indiana, United States

Universitaetsklinikum Wuerzburg

Würzburg, Germany