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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 22 Mar 2018

At a glance

  • Drugs Abaloparatide (Primary) ; Teriparatide
  • Indications Fracture; Postmenopausal osteoporosis
  • Focus Registrational; Therapeutic Use
  • Acronyms ACTIVE
  • Sponsors Radius Health Inc.
  • Most Recent Events

    • 22 Mar 2018 According to a Radius Health media release, Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has communicated a negative trend vote on the benefit-risk balance for the Company's marketing authorization application (MAA) for abaloparatide-SC and CHMP adopt a negative opinion on the MAA on March 22, 2018.
    • 15 Dec 2017 According to a Radius Health media release,the Committee for Medicinal Products for Human Use (CHMP),will issue a third Day-180 List of Outstanding Issues. As part of its on-going risk-benefit assessment, the CHMP has informed the Company that it intends to refer the MAA to a scientific advisory group for additional advice. CHMP opinion regarding the MAA IS expected during the first half of 2018.
    • 08 Nov 2017 Results assessing fracture reduction with Abaloparatide followed by 24 months of Alendronate (from ACTIVE baseline to the end of ACTIVExtend) presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top