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

NCT07366086 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-18
Primary Completion
2028-05-21
Completion
2028-05-21

Countries

  • United States
  • Germany
  • Japan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07366086 on ClinicalTrials.gov