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A Randomized, Double-blind, Placebo-controlled, Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of Abaloparatide-SC for the Treatment of Men With Osteoporosis

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Trial Profile

A Randomized, Double-blind, Placebo-controlled, Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of Abaloparatide-SC for the Treatment of Men With Osteoporosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Jan 2024

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At a glance

  • Drugs Abaloparatide (Primary)
  • Indications Fracture; Male osteoporosis
  • Focus Registrational; Therapeutic Use
  • Acronyms ATOM
  • Sponsors Radius Health Inc.

    • Most Recent Events

    • 15 Nov 2023 Results assessing the effects of abaloparatide on cortical and trabecular compartments of the proximal femur in men with osteoporosis using 3D-DXA modeling presented at the ACR Convergence 2023.
    • 20 Dec 2022 According to an Radius Health Inc. media release, the U.S. Food and Drug Administration (FDA) has approved TYMLOS (abaloparatide) as a treatment to increase bone density in men with osteoporosis at high risk of fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or in patients who have failed or are intolerant to other available osteoporosis therapy, based on data from this trial.
    • 01 Dec 2022 Results assessing efficacy and safety of abaloparatide compared with placebo in men published in the Journal of Bone and Mineral Research
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