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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Aug 2017

At a glance

  • Drugs Abaloparatide (Primary) ; Alendronic acid
  • Indications Fracture; Postmenopausal osteoporosis
  • Focus Adverse reactions; Registrational
  • Acronyms ACTIVExtend
  • Sponsors Radius Health Inc.
  • Most Recent Events

    • 03 Aug 2017 According to a Radius Health media release, additional results from this trial will be presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting 2017.
    • 21 Jul 2017 According to a Radius Health media release, the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), issued a second Day-180 List of Outstanding Issues and requested additional data analyses related to the safety and efficacy of abaloparatide-SC in the process of their ongoing regulatory review. Radius expects the CHMP to issue an opinion regarding the MAA for abaloparatide-SC prior to the end of 2017.
    • 24 May 2017 Results published in the Radius Health media release.
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