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: 13 Jul 2018

At a glance

  • Drugs Romosozumab (Primary) ; Denosumab
  • Indications Postmenopausal osteoporosis
  • Focus Registrational; Therapeutic Use
  • Acronyms FRAME
  • 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 Jun 2018 Results presented at the 19th Annual Congress of the European League Against Rheumatism
    • 07 Jun 2018 According to the UCB media release, data from this trial will be presented at the Annual European Congress of Rheumatology (EULAR 2018).
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