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A Randomized, Double-blind, Placebo-Controlled, Comparative Multicenter Phase 3 Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Injection for Prevention of Fracture in Ambulatory Postmenopausal Women With Severe Osteoporosis and at Risk of Fracture

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Trial Profile

A Randomized, Double-blind, Placebo-Controlled, Comparative Multicenter Phase 3 Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Injection for Prevention of Fracture in Ambulatory Postmenopausal Women With Severe Osteoporosis and at Risk of Fracture

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Apr 2023

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At a glance

  • Drugs Abaloparatide (Primary) ; Teriparatide
  • Indications Postmenopausal osteoporosis; Vertebral fracture
  • Focus Registrational; Therapeutic Use
  • Acronyms ACTIVE
  • Sponsors Radius Health Inc.

Most Recent Events

  • 01 Apr 2023 Results of post hoc analysis (n=911) of ACTIVE and ACTIVExtend published in the Journal of Bone and Mineral Research.
  • 01 Jul 2022 Results of a subgroup analysis described 2D- and 3D-DXA data for hip subregions published in the Journal of Clinical Densitometry
  • 04 Nov 2021 According to a Radius Health media release, the company has resubmitted abaloparatide-SC dossier to the EMA for potential approval in the EU.

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