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).
Phase of Trial: Phase III
Latest Information Update: 20 Mar 2015
At a glance
- Drugs Denosumab (Primary) ; Alendronic acid
- Indications Male osteoporosis; Postmenopausal osteoporosis; Vertebral fracture
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms DIRECT
- Sponsors Daiichi Sankyo Company
- 16 Oct 2012 Results presented at the 34th Annual Meeting of the American Society for Bone and Mineral Research.
- 15 Oct 2012 Primary endpoint 'Vertebral-fractures' has been met, according to a Daiichi Sankyo media release.
- 15 Oct 2012 Primary endpoint 'Fracture-rate' has been met, according to a Daiichi Sankyo media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History