A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
Phase of Trial: Phase III
Latest Information Update: 08 Jan 2018
At a glance
- Drugs Romosozumab (Primary) ; Denosumab
- Indications Postmenopausal osteoporosis
- Focus Registrational; Therapeutic Use
- Acronyms FRAME
- Sponsors Amgen
- 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 assessing fracture risk reduction after 12 months of Romosozumab followed by Denosumab through 36 months in the extension of this study, presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting.
- 08 Nov 2017 Results characterizing the bone mineral density gains and the effect of building bone with Romosozumab on fracture risk reduction upon transition to denosumab, presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History