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

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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

Most Recent Events

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.

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