Denosumab China Phase III Study

Summary

This study is to evaluate the efficacy and safety of denosumab 60 milligrams (mg) for 12 month treatment in Chinese postmenopausal women with osteoporosis at increased risk of fracture.

Timeline

Start

2014-01

Primary completion

2015-08

Completion

2015-08

Outcome

Met primary endpoint

registry analysis (superiority or other test); Denosumab 60 mg vs Placebo; p <0.0001; Mean Difference (Net) 4.42 (95% CI 3.67 to 5.18); ANCOVA NCT02014467 ↗

Drugs

Indications