A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis.
Phase of Trial: Phase III
Latest Information Update: 16 Feb 2018
At a glance
- Drugs Romosozumab (Primary) ; Alendronic acid
- Indications Postmenopausal osteoporosis
- Focus Registrational; Therapeutic Use
- Acronyms ARCH
- Sponsors Amgen
- 16 Jan 2018 Results comparing efficacy of romosozumab followed by alendronate reduced fractures vs alendronate alone, were published in the Annals of Internal Medicine.
- 08 Jan 2018 According to an Amgen media release, the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for EVENITY (romosozumab) for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture based on data from FRAME, ARCH and BRIDGE studies.
- 08 Nov 2017 Results presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History