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

Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Oct 2019

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At a glance

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

    • 18 Oct 2019 According to an UCB, Amgen media release, the CHMP's recommendation will now be reviewed by the European Commission (EC) with decision expected by year-end 2019.
    • 18 Oct 2019 According to an UCB, Amgen media release, following a re-examination procedure, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion recommending Marketing Authorization for EVENITY(romosozumab) for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture and with no history of myocardial infarction or stroke.
    • 27 Jun 2019 According to an Amgen, UCB Media release, the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Application for EVENITY(romosozumab) for the treatment of severe osteoporosis based on the results of 3 pivotal Phase 3 studies FRAME, ARCH and BRIDGE. Also the companies intend to submit a written notice for a re-examination by the Committee for Medicinal Products for Human Use.
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