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: 10 Oct 2017

At a glance

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

    • 08 Sep 2017 According to an Amgen media release, dat from this strial will be presented at 2017 Annual Meeting of the American Society for Bone and Mineral Research (ASBMR).
    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top