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An Extension Study to Evaluate 24 Months of Standard-of-Care Osteoporosis Management Following Completion of 18 Months of BA058 or Placebo Treatment in Protocol BA058-05-003

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Trial Profile

An Extension Study to Evaluate 24 Months of Standard-of-Care Osteoporosis Management Following Completion of 18 Months of BA058 or Placebo Treatment in Protocol BA058-05-003

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Apr 2023

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At a glance

  • Drugs Abaloparatide (Primary) ; Alendronic acid
  • Indications Fracture; Postmenopausal osteoporosis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ACTIVExtend
  • 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.
    • 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.
    • 24 Mar 2021 According to a Radius Health media release, the company intend to re-file abaloparatide in European union by Q4 2021 and has notified the European Medicines Agency (EMA) of its intentions. This notification was delivered by submitting a "Letter of Intent" to the agency.
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