A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis.

Trial Profile

A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis.

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jul 2018

At a glance

  • Drugs Romosozumab (Primary) ; Alendronic acid
  • Indications Postmenopausal osteoporosis
  • Focus Registrational; Therapeutic Use
  • Acronyms ARCH
  • Sponsors Amgen
  • Most Recent Events

    • 13 Jul 2018 According to MabVax Therapeutics media release, the company has resubmitted the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for romosozumab, for the treatment of osteoporosis in postmenopausal women at high risk for fracture, along with data from BRIDGE and ARCH studies.
    • 16 Jan 2018 Results comparing efficacy of romosozumab followed by alendronate reduced fractures vs alendronate alone, were published in the Annals of Internal Medicine.
    • 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.
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