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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07366086

Enrollment

Registered

2026-01-26

Start date

2026-03-18

Completion date

2028-04-19

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteogenesis Imperfecta

Keywords

Romosozumab, EVENITY

Brief 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.

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 19 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Number of Participants with Adverse Events (AEs)	Up to 9 months

Countries

Germany, Japan, United States

Contacts

CONTACTAmgen Call Center

medinfo@amgen.com866-572-6436

STUDY_DIRECTORMD

Amgen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026