A Randomized, Double-Blind, Placebo-controlled Phase 3 Study Evaluating Efficacy and Safety of Denosumab in Japanese Osteoporotic Subjects With Prevalent Fragility Vertebral Fracture(s) (DIRECT)

NCT00680953 Phase 3 COMPLETED Results posted

Evaluate the efficacy and safety of denosumab in the treatment of involutional (postmenopausal and senile) osteoporotic subjects with prevalent fragility vertebral fracture(s)

Details

Lead sponsor	Daiichi Sankyo Co., Ltd.
Phase	Phase 3
Status	COMPLETED
Enrolment	1262
Start date	2008-05
Completion	2012-07

Conditions

• Osteoporosis

Interventions

• Denosumab
• Placebo
• Alendronate sodium hydrate

Primary outcomes

• Incidence of New or Worsening Vertebral Fractures in Osteoporotic Subjects Treated With Denosumab Compared to Placebo — Baseline to 24 months

Countries

Japan