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
Price :
$35
*
At a glance
- Drugs Abaloparatide (Primary) ; Alendronic acid
- Indications Fracture; Postmenopausal osteoporosis
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms ACTIVExtend
- Sponsors Radius Health Inc.
- 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.