title: DESIGNING DRUG TRIALS FOR SARCOPENIA IN OLDER ADULTS WITH HIP FRACTURE - A TASK FORCE FROM THE INTERNATIONAL CONFERENCE ONFRAILTY AND SARCOPENIA RESEARCH (ICFSR).
abstract: In May 2012, a Sarcopenia Consensus Summit was convened by the Foundation of the National Institutes of Health (FNIH), National Institute of Aging (NIA), and the U.S. Food and Drug Administration (FDA); and co-sponsored by five pharmaceutical companies. At this summit, sarcopenia experts from around the world worked to develop agreement on a working definition of sarcopenia, building on the work of previous efforts to generate a consensus. With the ultimate goal of improving function and independence in individuals with sarcopenia, the Task Force focused its attention on people at greatly increased risk of muscle atrophy as a consequence of hip fracture. The rationale for looking at this population is that since hip fracture is a recognized condition, there is a clear regulatory path forward for developing interventions. Moreover, patients with hip fracture may provide an appropriate population to advance understanding of sarcopenia, for example helping to define diagnostic criteria, develop biomarkers, understand the mechanisms that underlie the age-related loss of muscle mass and strength, and identify endpoints for clinical trials that are reliable, objective, and clinically meaningful. Task Force members agreed that progress in treating sarcopenia will require strengthening of partnerships between academia, industry, and government agencies, and across continents to reach consensus on diagnostic criteria, optimization of clinical trials design, and identification of improved treatment and preventive strategies. In this report, the main results of the Task Force discussion are presented.
authors.affiliation: Centre Hospitalier Universitaire de Toulouse, Toulouse, France ; Inserm UMR1027, Université de Toulouse, Toulouse, France.
authors.forename: B
authors.initials: B
authors.lastname: Vellas
authors.affiliation: Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, USA.
authors.forename: R
authors.initials: R
authors.lastname: Fielding
authors.affiliation: Muscle Metabolism Discovery Performance Unit, GlaxoSmithKline, Raleigh-Durham, NC, USA.
authors.forename: R
authors.initials: R
authors.lastname: Miller
authors.affiliation: Centre Hospitalier Universitaire de Toulouse, Toulouse, France.
authors.forename: Y
authors.initials: Y
authors.lastname: Rolland
authors.affiliation: Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: S
authors.initials: S
authors.lastname: Bhasin
authors.affiliation: Department of Epidemiology & Public Health Director, University of Maryland School of Medicine, Baltimore, MD, USA.
authors.forename: J
authors.initials: J
authors.lastname: Magaziner
authors.affiliation: Department of Geriatrics and Aging Research, University of Zurich, Zurich, Switzerland.
authors.forename: H
authors.initials: H
authors.lastname: Bischoff-Ferrari
keywords: Sarcopenia; aging; clinical trials; hip fracture; skeletal muscle