A single, randomized, open label, active-controlled, non-inferiority bioequivalence pivotal study of TYMLOS to treat patients with postmenopausal osteoporosis.

Trial Profile

A single, randomized, open label, active-controlled, non-inferiority bioequivalence pivotal study of TYMLOS to treat patients with postmenopausal osteoporosis.

Planning
Phase of Trial: Phase III

Latest Information Update: 01 Mar 2018

At a glance

  • Drugs Abaloparatide (Primary) ; Abaloparatide
  • Indications Postmenopausal osteoporosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Radius Health Inc.
  • Most Recent Events

    • 01 Mar 2018 According to a Radius media release, company expects to initiate this pivotal trial in mid-2019.
    • 01 Mar 2018 According to a Radius media release, based on the results of this study, FDA has agreed to provide an approval for Abaloparatide-Transdermal Patch (TD) to treat patients with postmenopausal osteoporosis .
    • 02 Nov 2017 The company has scheduled a meeting with the FDA in January 2018 to align on a regulatory pathway for this trial, as reported in a Radius media release.
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