drugset / Trial / NCT01495000

A Study in Indian Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab

NCT01495000 ↗

Phase 3 Completed 250 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine if denosumab is effective in increasing bone mineral density at the lumbar spine in Indian postmenopausal women with osteoporosis.

Timeline

Start
2012-01
Primary completion
2013-02
Completion
2013-02

Outcome

Met primary endpoint

registry analysis (superiority or other test); Denosumab 60 mg vs Placebo; p <0.0001; Mean Difference (Final Values) 3.05 (95% CI 1.91 to 4.19); ANCOVA NCT01495000 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Denosumab Monoclonal antibody 60 mg Subcutaneous