Biomarkers Consortium - Sarcopenia as a Valid Biomarker for Identifying Individuals at Risk of Disability

This project completed in August 2019.

The Biomarkers Consortium’s Sarcopenia as a Valid Biomarker for Identifying Individuals at Risk of Disability (Sarcopenia 2 Project) seeks to establish evidence-based cut-points for muscle mass and strength and determine their predictive validity for clinically meaningful outcomes (such as mobility, fractures, hospitalization and death); evaluate relative strength as a discriminator for mobility limitation and incident disability; and explore the potential usefulness of sarcopenia as a clinical endpoint in randomized clinical trials. The concept of sarcopenia as a clinical biomarker to identify older adults at risk of physical disability and poor health outcomes is based on the measurement of lean soft tissue mass and muscle strength. It has considerable appeal to the practicing clinicians who care for these patients and to the pharmaceutical companies that are engaged in the development of therapies to prevent or to treat functional limitations in older adults.

Sarcopenia 2 builds on the results of the Sarcopenia 1 Project, which developed the initial sarcopenia criteria for predicting physical disability and clinically meaningful patient-important health outcomes. The Sarcopenia 2 Project will pool together additional clinical data sets from epidemiologic studies and clinical trials of older adults, in whom the disability rates are higher and the potential for treatment may be much greater, to validate and extend the findings from Sarcopenia 1.

The International Sarcopenia Definitions and Outcomes Conference that will be held in Boston on November 13, 2018 to review the Position Statements prepared by the Consortium and vetted with the International Expert Panel, followed by a formal vote on these position statements by the Expert Panel.

Goals

  • Establish evidence-based cut-points for muscle mass and strength and determine their predictive validity for clinically meaningful outcomes (such as mobility, fractures, hospitalization and death).
  • Evaluate relative strength as a discriminator for mobility limitation and incident disability.
  • Explore the potential usefulness of sarcopenia as a clinical endpoint in randomized clinical trials.

Results & Accomplishments

Scientific Publications

Establishing the Link Between Lean Mass and Grip Strength Cut-points With Mobility Disability and Other Health Outcomes: Proceedings of the Sarcopenia Definition and Outcomes Consortium Conference. Cawthon PM, Travison TG, Patel S, et al. The journals of gerontology. Series A, Biological sciences and medical sciences. glz081. 14 March 2019.

Strong Relation between Muscle Mass Determined by D3-creatine Dilution, Physical Performance and Incidence of Falls and Mobility Limitations in a Prospective Cohort of Older Men. Cawthon PM et al. The Journals of Gerontology; A Series A, gly129. 12 June 2018.

Partners

Public-Sector Partners:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Aging (NIA)
U.S. Food and Drug Administration (FDA)
 

Private-Sector Partners:
Abbott Nutrition*
Alliance for Aging Research
American Society for Bone and Mineral Research*
Astellas Pharma Inc.*
Hebrew SeniorLife
National Dairy Institute*
Partners Healthcare
Pfizer Inc
Regeneron Pharmaceuticals, Inc.*

Academic Partners:
Boston Medical Center
Columbia University
Harvard
San Francisco Coordinating Center
Tufts
University of California
University of Central Florida
University of Connecticut
University of Florida
University of Maryland
University of Pittsburgh

*Provided financial or in-kind support for this program.

FNIH Contact

Helen Heymann, MMSC, Scientific Project Manager, Metabolic Disorders; hheymann@fnih.org