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

Identifying and treating older adults at increased risk of developing physical disabilities

The Problem
Compared to younger adults, older adults are at increased risk for developing physical disabilities and limited mobility, yet researchers struggle to predict which individuals are at particular risk, which prevents early intervention.
The Solution
The Sarcopenia 2 Project assessed whether measurements such as muscle mass and strength and relative strength could enable researchers to predict older adults’ likelihood of developing physical disabilities and related complications.

This project completed in August 2019.

Overview

The Biomarkers Consortium’s Sarcopenia as a Valid Biomarker for Identifying Individuals at Risk of Disability (Sarcopenia 2 Project) sought to establish evidence-based cut-points for biomarkers of muscle mass and strength; determine these biomarkers’ validity in predicting clinically meaningful outcomes (e.g., mobility, fractures, hospitalization and death); evaluate the ability of relative strength to discriminate between mobility limitation and incident disability; and explore the potential usefulness of sarcopenia as a clinical endpoint in randomized controlled clinical trials. Using sarcopenia as a clinical biomarker to identify older adults at risk of physical disability and poor health outcomes involves measuring lean soft tissue mass and muscle strength. This approach has considerable appeal for practicing clinicians who care for these patients and for pharmaceutical companies engaged in development of therapies to prevent or treat functional limitations in older adults.

The Sarcopenia 2 Project built on the results of the Sarcopenia 1 Project, which developed the initial sarcopenia criteria for predicting physical disability and clinically meaningful health outcomes for patients. The Sarcopenia 2 Project combined additional clinical datasets from epidemiologic studies and clinical trials of older adults to validate and extend the findings from the Sarcopenia 1 Project.

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.

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

Results & Accomplishments

Publications

This project has led to nine peer-reviewed scientific publications (listed above).

Position Statements Formally Approved

Expert participants at the International Sarcopenia Definitions and Outcomes Conference, held on November 13, 2018, reviewed and voted to formally approve the Position Statements prepared by the Sarcopenia 2 Project.

Scientific Publications

Media

  • FNIH Sarcopenia Announcement on 7 Publications (August 2020)
  • FNIH Sarcopenia Q&A with PIs (September 2020)