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Open-label Extension of Study 20130173 of Denosumab in Children and Young Adults With Osteogenesis Imperfecta

NCT03638128 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2022-12-20

Study results available
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Summary

To evaluate long-term safety of denosumab in children/young adults with pediatric osteogenesis imperfecta (OI) who completed the prior study 20130173 (NCT02352753).

Conditions

  • Osteogenesis Imperfecta (OI)

Interventions

DRUG

Denosumab

Solution for injection

DRUG

Alternative osteoporosis medications

Alternative osteoporosis medication/s at the discretion of the investigator.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-26
Primary Completion
2022-03-28
Completion
2022-03-28
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03638128 on ClinicalTrials.gov