A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of Romosozumab (AMG 785) With Placebo in Men With Osteoporosis

Trial Profile

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of Romosozumab (AMG 785) With Placebo in Men With Osteoporosis

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Oct 2017

At a glance

  • Drugs Romosozumab (Primary)
  • Indications Osteoporosis
  • Focus Registrational; Therapeutic Use
  • Acronyms BRIDGE
  • Sponsors Amgen
  • Most Recent Events

    • 16 Jul 2017 According to an Amgen media release, data from FRAME, ARCH and BRIDGE studies will be submitted to US FDA to support Biologics License Application (BLA) for EVENITY (romosozumab) as a treatment for osteoporosis.
    • 10 Jun 2017 Biomarkers information updated
    • 19 Dec 2016 According to Amgen media release, based on results from this and FRAME study an application seeking marketing approval of romosozumab for treatment of osteoporosis has been submitted for review to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.
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