Biomarkers Consortium - Establish Guidelines for Initial Diagnostic Criteria for “Sarcopenia with Clinically Important Weakness” and Associated Evidence for Treatment Benefit

This project completed in June 2010

The Sarcopenia 1 project launched in 2010 and aimed to establish the first evidence-based definition of sarcopenia (muscle weakness), which is still not recognized as a medical condition. In the first phase, data was pooled from 10 longitudinal epidemiologic studies such as Health ABC, MrOS, SOF, Framigham, InChianti, Rancho Bernanrdo, etc. to generate a database of over 10,000 subjects. The pooled data was analyzed by a multisector project team to establish an evidence based definition of sarcopenia considering body mass and strength measurements. The results of these analyses were presented at a large Consensus Summit that included the broader scientific community: industry, health organizations, NIH, academia and the FDA. The second phase of the project published the results of the analyses and the findings of the consensus meeting in a peer reviewed journal. A series of six special articles were published online in April 2014, in the Journals of Gerontology: Medical Sciences and provided data-driven diagnostic criteria for clinically relevant weakness and low muscle mass. The success of Sarcopenia 1 led to a follow-on project, Sarcopenia 2, which launched in 2016 and seeks to establish evidence-based cut-points for muscle mass and strength and determine their predictive validity for clinically meaningful outcomes.

Goals

  • Support secondary analyses of existing data in order to develop a body of evidence that can support a definition of a clinical indication of clinically important weakness related to low muscle mass.
  • Present the evidence at a conference organized by the FNIH and the leading professional organizations dedicated to health care of the older adults to discuss consensus around the findings.

Results & Accomplishments

The FNIH Sarcopenia 1 Project recommendations are a significant advancement for the sarcopenia field. They are the first data-driven criteria, based on their relations with a clinical outcome (slow gait speed) that is directly relevant to muscle impairment. Also, these criteria are perhaps the most generalizable to date, because pooling data across multiple cohorts for analyses yielded large sample sizes representing a wide range of community-dwelling older adults. Additionally, this work has been referenced extensively for characterizations of additional cohorts and the FNIH definitions applied to several subsequent studies.

Scientific Publications

The Position Statements of the Sarcopenia Definition and Outcomes Consortium. Bhasin, S., Travison, T.G., Manini, T. M., Patel, S., Pencina, K.M., et al. (2019)

The FNIH Sarcopenia Project: Rationale, Study Description, Conference Recommendations, and Final Estimates. Studenski, S. A., Peters, K. W., Allen, D. E., Cawthon, P. M., Mclean, R. R., Harris, T. B., Ferrucci, L., Guralnik, J. M., Fragala, M. S., Kenny, A. M., Kiel, D. P., Kritchevsky, S. B., Shardell, M. D., Dam, T. L., & Vassileva, M. T. J Gerontol A Biol Sci Med Sci.2014; 69(5):547-558.

Grip Strength Cutpoints for the Identification of Clinically Relevant Weakness. Alley, D. E., Shardell, M. D., Peters, K. W., McLean, R. R., Dam, T. L., Kenny, A. M., Fragala, M. S., Harris, T. B., Kiel, D. P., Guralnik, J. M., Ferrucci, L., Kritchevsky, S. B., Studenski, S. A., Vassileva, M. T., & Cawthon, P. M. J Gerontol A Biol Sci Med Sci. 2014; 69(5), 559-566.

Cutpoints for Low Appendicular Lean Mass That Identify Older Adults With Clinically Significant Weakness. Cawthon, P. M., Peters, K. W., Shardell, M. D., McLean, R. R., Dam, T. L., Kenny, A. M., Fragala, M. S., Harris, T. B., Kiel, D. P., Guralnik, J. M., Ferrucci, L., Kritchevsky, S. B., Vassileva, M. T., Studenski, S. A., & Alley, D. E. J Gerontol A Biol Sci Med Sci. 2014; 69(5): 567-575.

Criteria for Clinically Relevant Weakness and Low Lean Mass and Their Longitudinal Association with Incident Mobility Impairment and Mortality: The Foundation for the National Institutes of Health (FNIH) Sarcopenia Project. Peters, K. W., Ferrucci, L., Guralnik, J. M., Kritchevsky, S. B., Kiel, D. P., Vassileva, M. T., Xue, Q., Perera, S., Studenski, S. A., & Dam, T. L. J Gerontol A Biol Sci Med Sci. 2014; 69(5): 576-583.

An Evidence-Based Comparison of Operational Criteria for the Presence of Sarcopenia. Dam, T. L., Peters K. W., Fragala, M. F., Cawthon, P. M., Harris, T. B., McLean, R. R., Shardell, M., Alley, D. E., Kenny, A., Ferrucci, L., Guralnik, J., Kiel, D. P., Kritchevsky, S., Vassileva, M. T., & Studenski, S. A. J Gerontol A Biol Sci Med Sci. 2014; 69(5), 584-590.

Strength and function response to clinical interventions of older women categorized by weakness and low lean mass using classifications from the Foundation for the National Institutes of Health Sarcopenia Project. Fragala, M, Dam, T., Barber, V., Judge J., Studenski S., Cawthon, P., Harris, T., Ferrucci, L., Guralnik, J., Kiel D., Kritchevsky S., Shardell, M., Vassileva, M., Kenny, A. J Gerontol A Biol Sci Med Sci. 2014: epub ahead of print.

Partners

Abbott
Amgen, Inc.
California Pacific Medical Center Research Institute
Columbia University
Dairy Research Institute
Food and Drug Administration
Harvard Medical School
Hebrew SeniorLife
Eli Lilly and Company
Merck & Co., Inc
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute on Aging (NIA)
Novartis Pharmaceuticals Corporation
University of Central Florida
University of Connecticut
University of Maryland
University of Pittsburgh

Contact

Tania Kamphaus, Scientific Program Manager, Metabolic Disorders, TKamphaus@fnih.org