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).

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).

Completed
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
  • Most Recent Events

    • 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.
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