Trials / Terminated
TerminatedNCT02352753
Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 153 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Denosumab | Subcutaneous (SC) injection. |
Timeline
- Start date
- 2015-06-24
- Primary completion
- 2022-03-26
- Completion
- 2022-03-26
- First posted
- 2015-02-02
- Last updated
- 2022-12-28
- Results posted
- 2022-12-28
Locations
49 sites across 13 countries: United States, Australia, Belgium, Bulgaria, Canada, Czechia, France, Germany, Hungary, Italy, Poland, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02352753. Inclusion in this directory is not an endorsement.