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) 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.
- 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.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Aging (NIA)
U.S. Food and Drug Administration (FDA)
Alliance for Aging Research
American Society for Bone and Mineral Research*
Astellas Pharma Inc.*
National Dairy Institute*
Regeneron Pharmaceuticals, Inc.*
Boston Medical Center
San Francisco Coordinating Center
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.
Helen Heymann, MMSC, Senior Scientific Project Manager, Metabolic Disorders; [email protected]
Results & Accomplishments
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.
- Application of Cut-Points for Low Muscle Strength and Lean Mass in Mobility-Limited Older Adults. Grosicki G.J. et al. The Journal of the American Geriatrics Society (JAGS). Volume 75, Issue 7. July 2020.
- Application of SDOC Cut Points for Low Muscle Strength for Recovery of Walking Speed After Hip Fracture. Orwig D.L. et al. The Journal of the American Geriatrics Society (JAGS). Volume 75, Issue 7, pages 1379-1385. 7 July 2020.
- Application of Selected Muscle Strength and Body Mass Cut-Points for the Diagnosis of Sarcopenia in Men and Women with or at risk for HIV Infection. Erlandson K.M. et al. The Journals of Gerontology: Series A, Volume 75, Issue 7, July 2020, pages 1338-1345.
- Identification of Sarcopenia Components That Discriminate Slow Walking Speed: A Pooled Data Analysis. Manini T.M., et al. The Journal of the American Geriatrics Society (JAGS). Volume 75, Issue 7. 7 July 2020.
- Putative Cut-Points in Sarcopenia Components and Incident Adverse Health Outcomes: An SDOC Analysis. Cawthorn P.M. et al. The Journal of the Geriatrics Society (JAGS). Volume 75, Issue 7. 7 July 2020.
- Sarcopenia Definition & Outcomes Consortium Defined Low Grip Strength in Two Cross-Sectional, Population-Based Cohorts. Patel S.M. et al. The Journal of the American Geriatrics Society (JAGS). Volume 75, Issue 7. 7 July 2020.
- The Position Statements of the Sarcopenia Definition and Outcomes Consortium. Bhasin S et al. The Journal of the American Geriatrics Society (JAGS). 9 March 2020.
- 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.
- FNIH Sarcopenia Announcement on 7 Publications (August 2020)
- FNIH Sarcopenia Q&A with PIs (September 2020)