Recruiting
Phase 3

Romosozumab

Sponsor:

Amgen

Code:

NCT07366086

Conditions

Osteogenesis Imperfecta

Eligibility Criteria

Sex: All

Age: 5 - 19

Healthy Volunteers: Not accepted

Interventions

Vitamin D

Calcium

Study Details

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.

Conditions

Osteogenesis Imperfecta

Study ID

NCT07366086

Start date

Mar 18, 2026

Status verified date

Jun, 2026

Completion date

Apr 19, 2028

Anticipated

Primary completion date

Apr 19, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 19

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

71 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Standard of Care

Participants who completed romosozumab trial 20200105 will continue to receive standard of care treatment (calcium and vitamin D), as determined by the investigator and local guidance. No investigational drug product will be administered in this trial as this is a safety follow-up.

Interventions

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.

Primary outcome measure

  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 9 months ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

More Information

Sponsor

Amgen

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

  • Romosozumab
  • EVENITY

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Amgen on 2026-06-22.