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: 21 Aug 2017

At a glance

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

    • 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.
    • 17 Jun 2017 Results presented at the 18th Annual Congress of the European League Against Rheumatism
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