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Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI — OI  

Osteogenesis Imperfecta Clinical Trial

Official title:
To Evaluate the Effect of Denosumab in Lumbar Spine Bone Mineral Density (BMD) Z-score at 12 Months, as Assessed by Dual-energy X-ray Absorptiometry (DXA), in Children 2 to 17 Years of Age (at the Time of Screening) on a 3-Month Dosing Regimen With OI

Clinical Trial Summary

This is a prospective, multicenter, single-arm study in children 2 to 17 years of age with OI to evaluate efficacy and safety of denosumab.

Clinical Trial Description

To evaluate the effect of denosumab in lumbar spine bone mineral density (BMD) Z-score at 12 months, as assessed by dual-energy X-ray absorptiometry (DXA), in children 2 to 17 years of age (at the time of screening) on a 3-Month Dosing Regimen with osteogenesis imperfecta (OI) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02352753
Study type Interventional
Source Amgen
Contact
Status Terminated
Phase Phase 3
Start date June 24, 2015
Completion date March 26, 2022
View Details
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