A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

Trial Profile

A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Nov 2017

At a glance

  • Drugs Romosozumab (Primary) ; Denosumab
  • Indications Fracture; Postmenopausal osteoporosis
  • Focus Registrational; Therapeutic Use
  • Acronyms FRAME
  • Sponsors Amgen
  • Most Recent Events

    • 08 Nov 2017 Results characterizing the bone mineral density gains and the effect of building bone with Romosozumab on fracture risk reduction upon transition to denosumab, presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting.
    • 20 Oct 2017 According to an Amgen Astellas BioPharma media release, Of overall 7,180 enrolled subjects in this study 492 were Japanese. and Further analysis for Japanese sub group will be submitted to a future medical conference and for publication.
    • 20 Oct 2017 Data were presented in an Amgen Astellas BioPharma Media Release.
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