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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Amgen
Study ID
NCT07366086
Phase
PHASE3
Status
Recruiting
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Conditions

  • Osteogenesis Imperfecta

Eligibility Criteria

Sex
ALL
Age
5 Years - 19 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 18, 2026
Status verified
May 2026
Primary completion
May 21, 2028
Completion
May 21, 2028

Study Design

Enrollment
71 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana UniversityIndianapolisIndiana46202-

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By research site
Indiana University· Indianapolis, IN

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