A Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals

Trial Profile

A Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals

Completed
Phase of Trial: Phase III

Latest Information Update: 18 Oct 2017

At a glance

  • Drugs Denosumab (Primary) ; Risedronic acid
  • Indications Corticosteroid-induced osteoporosis
  • Focus Registrational; Therapeutic Use
  • Acronyms GIOP
  • Sponsors Amgen
  • Most Recent Events

    • 09 Oct 2017 According to an Amgen media release, U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Prolia (denosumab) for the treatment of patients with glucocorticoid-induced osteoporosis (GIOP) The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of May 28, 2018.
    • 31 Jul 2017 According to an Amgen media release, the company has submitted a supplemental Biologics License Application (sBLA) to the US FDA for Prolia (denosumab) for the treatment of patients with glucocorticoid-induced osteoporosis (GIOP). The submission is based on this trial.
    • 06 Jul 2017 Status changed from active, no longer recruiting to completed.
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