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: 10 Oct 2017
At a glance
- Drugs Romosozumab (Primary) ; Denosumab
- Indications Fracture; Postmenopausal osteoporosis
- Focus Registrational; Therapeutic Use
- Acronyms FRAME
- Sponsors Amgen
- 08 Sep 2017 According to an Amgen media release, dat from this strial will be presented at 2017 Annual Meeting of the American Society for Bone and Mineral Research (ASBMR).
- 16 Jul 2017 According to an Amgen media release, The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologics License Application (BLA) for EVENITY (romosozumab) as a treatment for postmenopausal women with osteoporosis, and asked for resubmission along with data from BRIDGE and ARCH studies.
- 17 Jun 2017 Results assessing the effect of Romosozumab on clinical vertebral fracture incidence over 12months, presented at the 18th Annual Congress of the European League Against Rheumatism.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History