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: 10 Aug 2017

At a glance

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

    • 26 Jul 2017 This study has been completed in Slovakia (End Date 29-06-2017).
    • 25 Jul 2017 Status changed from active, no longer recruiting to completed.
    • 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 postmenopausal women with osteoporosis.
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