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

Amgen

Status and phase: Begins enrollment this month; Phase 3

Conditions: Osteogenesis Imperfecta

Treatments: Dietary Supplement: Calcium; Dietary Supplement: Vitamin D

Study type: Interventional

Funder types: Industry

Identifiers

NCT07366086

2023-503293-21-00 (EU Trial (CTIS) Number)

20220043

Details and patient eligibility

About

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.

Enrollment: 71 estimated patients

Sex: All

Ages: 5 to 19 years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

71 participants in 1 patient group

Standard of Care

Other group

Description:

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.

Treatment:

Dietary Supplement: Vitamin D

Dietary Supplement: Calcium