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: 16 Jul 2017

At a glance

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

    • 16 Jul 2017 According to an Amgen media release, The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologics License Application (BLA) for EVENITY (romosozumab) as a treatment for postmenopausal women with osteoporosis, and asked for resubmission along with data from BRIDGE and ARCH studies.
    • 17 Jun 2017 Results assessing the effect of Romosozumab on clinical vertebral fracture incidence over 12months, presented at the 18th Annual Congress of the European League Against Rheumatism.
    • 15 Jun 2017 According to a UCB media release, data from this trial will be presented at the Annual European Congress of Rheumatology (EULAR) 2017.
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