RecruitingPhase 3NCT07366086

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

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


Sponsor

Amgen

Enrollment

71 participants

Start Date

Mar 18, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 5 YearsMax Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Calcium and Vitamin D for people with osteogenesis imperfecta. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 5 Years to 19 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 University

Indianapolis, Indiana, United States

Universitaetsklinikum Koeln

Cologne, Germany

Universitaetsklinikum Wuerzburg

Würzburg, Germany

Okayama Saiseikai Outpatient Center Hospital

Okayama, Okayama-ken, Japan

View Full Details on ClinicalTrials.gov

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NCT07366086


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