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
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.
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History