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Designing pharmaceutical trials for sarcopenia in frail older adults: EU/US task force recommendations

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The journal of nutrition, health & aging

Abstract

An international task force of academic and industry leaders in sarcopenia research met on December 5, 2012 in Orlando, Florida to develop guidelines for designing and executing randomized clinical trials of sarcopenia treatments. The Task Force reviewed results from previous trials in related disease areas to extract lessons relevant to future sarcopenia trials, including practical issues regarding the design and conduct of trials in elderly populations, the definition of appropriate target populations, and the selection of screening tools, outcome measures, and biomarkers. They discussed regulatory issues, the challenges posed by trials of different types of interventions, and the need for standardization and harmonization. The Task Force concluded with recommendations for advancing the field toward better clinical trials.

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Author information

Authors and Affiliations

  1. Inserm UMR1027 Inserm, Toulouse, France

    B. Vellas, Y. Rolland & M. Cesari

  2. University of Toulouse III, Toulouse, France

    B. Vellas, Y. Rolland & M. Cesari

  3. Gerontopole, Toulouse University Hospital, Toulouse, France

    B. Vellas, Y. Rolland, G. Abellan Van Kan & M. Cesari

  4. University of Florida, Gainesville, FL, USA

    M. Pahor & T. Manini

  5. Novartis Institutes for Biomedical Research, Cambridge, MA, USA

    D. Rooks

  6. University of Maryland School of Medicine, Baltimore, MD, USA

    J. M. Guralnik

  7. St. Louis University Medical School, St. Louis, MO, USA

    J. Morley

  8. University of Pittsburgh, Pittsburgh, PA, USA

    S. Studenski

  9. GlaxoSmithKline, Research Triangle Park, Durham, NC, USA

    W. Evans

  10. Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany

    C. Asbrand

  11. Neurotune AG, 8952, Schlieren, Switzerland

    R. Fariello

  12. Abbott Nutrition R&D, Columbus, OH, USA

    S. Pereira

  13. Lifespan Health Research Center, Boonshoft School of Medicine, Wright State University, Dayton, OH, USA

    W. M. C. Chumlea

  14. Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, USA

    R. Fielding

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  1. B. Vellas
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  2. M. Pahor
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  8. W. Evans
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Vellas, B., Pahor, M., Manini, T. et al. Designing pharmaceutical trials for sarcopenia in frail older adults: EU/US task force recommendations. J Nutr Health Aging 17, 612–618 (2013). https://doi.org/10.1007/s12603-013-0362-7

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  • DOI: https://doi.org/10.1007/s12603-013-0362-7

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