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Clinical Trials in Japan / NCT07366086
Recruiting Phase 3

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

NCT07366086 · tracked via the Priya Life Science Japan tracker
Sponsor
Amgen
Phase
Phase 3
Started
2026-03-18
Last updated
2026-06-22

Condition(s) studied

Osteogenesis Imperfecta

Investigational drug(s) / intervention(s)

Vitamin DCalcium

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

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

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.

Eligibility

Sex
ALL
Min age
5 Years
Max age
19 Years
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 investigational product (romosozumab) until the last protocol-specified dose or ended investigational product early. Exclusion Criteria: * Currently receiving treatment in another investigational device or drug trial, or less than 2 years since ending treatment on another investigational device or drug trial(ies) with the exception of trial 20200105. Other investigational procedures while participating in this trial are excluded. * Participant likely to not be available to complete all protocol-required trial visits or procedures, and/or to comply with all required trial procedures to the best of the participant and investigator's knowledge.

Primary outcome measure(s)

  • Number of Participants with Adverse Events (AEs) — Up to 9 months

Trial sites (4)

FacilityCityRegionStatus
Indiana University Indianapolis Indiana Recruiting
Universitaetsklinikum Koeln Cologne Germany Recruiting
Universitaetsklinikum Wuerzburg Würzburg Germany Recruiting
Okayama Saiseikai Outpatient Center Hospital Okayama Okayama-ken Recruiting

More Amgen trials in Japan

A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation Recruiting
Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104). Active, not recruiting
Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta Active, not recruiting
A Study of Subcutaneous Blinatumomab in Children With R/R and and MRD+ B-Cell Precursor Acute Lymphoblastic Leukemia Active, not recruiting
A Study Evaluating Anvumetostat in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion (MTAPESTRY 103) Active, not recruiting

Other trials for the same condition

Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta Active, not recruiting
Setrusumab in Pediatric Japanese Subjects With Osteogenesis Imperfecta Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07366086 on ClinicalTrials.gov ↗ ← All trials in Japan