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: 08 Jan 2018

At a glance

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

    • 08 Jan 2018 According to an Amgen media release, the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for EVENITY (romosozumab) for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture based on data from FRAME, ARCH and BRIDGE studies.
    • 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
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