NCT03638128

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

Multicenter, Single-arm Open-label Extension Study to Assess Long-term Safety and Efficacy of Current or Prior Treatment With Denosumab in Children/Young Adults With Osteogenesis Imperfecta

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed description

All participants who completed the prior denosumab study 20130173 (NCT02352753) were offered participation in this study (20170534). Participants could continue to receive denosumab once every 3 months (Q3M) or could receive denosumab once every 6 months (Q6M) or off-treatment observation only at the investigator's discretion. The study design allowed subjects to discontinue denosumab, resume denosumab, initiate alternative osteoporosis medication, discontinue alternative osteoporosis medication, or receive no treatment (observation only) at any time. Therefore results of this study were analyzed according to both baseline treatment and subsequent treatment trajectories.

Conditions

• Osteogenesis Imperfecta (OI)

Interventions

Type	Name	Description
DRUG	Denosumab	Solution for injection
DRUG	Alternative osteoporosis medications	Alternative osteoporosis medication/s at the discretion of the investigator.

Timeline

• Start date: 2018-07-26
• Primary completion: 2022-03-28
• Completion: 2022-03-28
• First posted: 2018-08-20
• Last updated: 2022-12-20
• Results posted: 2022-12-20

Locations

22 sites across 12 countries: United States, Australia, Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study