A multicenter, double blind, randomized, placebo and raloxifene controlled study to assess safety and efficacy of TSE-424 (bazedoxifene acetate) in the prevention of postmenopausal osteoporosis

Trial Profile

A multicenter, double blind, randomized, placebo and raloxifene controlled study to assess safety and efficacy of TSE-424 (bazedoxifene acetate) in the prevention of postmenopausal osteoporosis

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Jun 2014

At a glance

  • Drugs Bazedoxifene; Raloxifene
  • Indications Postmenopausal osteoporosis
  • Focus Adverse reactions; Pharmacodynamics; Registrational; Therapeutic Use
  • Sponsors Wyeth
  • Most Recent Events

    • 30 Sep 2010 Bazedoxifene has obtained approval in Spain from the Spanish Agency for Medicines and Healthcare Products (AEMPS) based on the results of this trial, according to a Pfizer and Almirall media release.
    • 25 Aug 2009 Actual end date (1 Sep 2004) added as reported by ClinicalTrials.gov.
    • 25 Sep 2008 Retrospective analysis presented at North American Menopause Society (NAMS) according to Wyeth media release.
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