Trial Profile
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).
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 09 Nov 2021
Price :
$35
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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
- 01 Nov 2020 Results published in the Journal of Bone and Mineral Metabolism
- 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.