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: 16 Jul 2017
At a glance
- Drugs Romosozumab (Primary) ; Denosumab
- Indications Fracture; Postmenopausal osteoporosis
- Focus Registrational; Therapeutic Use
- Acronyms FRAME
- Sponsors Amgen
- 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.
- 15 Jun 2017 According to a UCB media release, data from this trial will be presented at the Annual European Congress of Rheumatology (EULAR) 2017.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History