Recommendations for the conduct of clinical trials for drugs to treat or prevent sarcopenia

Cruz Jentoft AJ, Michel JP (2013) Sarcopenia: a useful paradigm for physical frailty. Eur Geriatr Med 4:102–105 Cruz-Jentoft AJ, Baeyens JP, Bauer JM et al (2010) Sarcopenia: European consensus on definition and diagnosis: report of the European working group on sarcopenia in older people. Age Ageing 39(4):412–423 Muscaritoli M, Anker SD, Argiles J et al (2010) Consensus definition of sarcopenia, cachexia and pre-cachexia: joint document elaborated by special interest groups (SIG) “cachexia-anorexia in chronic wasting diseases” and “nutrition in geriatrics”. Clin Nutr 29(2):154–159 Fielding RA, Vellas B, Evans WJ et al (2011) Sarcopenia: an undiagnosed condition in older adults. Current consensus definition: prevalence, etiology, and consequences. International working group on sarcopenia. J Am Med Dir Assoc 12(4):249–256 Wakabayashi H, Sakuma K (2014) Comprehensive approach to sarcopenia treatment. Curr Clin Pharmacol 9(2):171–180 Cooper C, Dere W, Evans W et al (2012) Frailty and sarcopenia: definitions and outcome parameters. Osteoporos Int 23(7):1839–1848 Cooper C, Fielding R, Visser M et al (2013) Tools in the assessment of sarcopenia. Calcif Tissue Int 93(3):201–210 Rizzoli R, Reginster JY, Arnal JF et al (2013) Quality of life in sarcopenia and frailty. Calcif Tissue Int 93(2):101–120 Newman AB, Kupelian V, Visser M et al (2006) Strength, but not muscle mass, is associated with mortality in the health, aging and body composition study cohort. J Gerontol A Biol Sci Med Sci 61(1):72–77 Delmonico MJ, Harris TB, Visser M et al (2009) Longitudinal study of muscle strength, quality, and adipose tissue infiltration. Am J Clin Nutr 90(6):1579–1585 Koster A, Ding J, Stenholm S et al (2011) Does the amount of fat mass predict age-related loss of lean mass, muscle strength, and muscle quality in older adults? J Gerontol A Biol Sci Med Sci 66(8):888–895 Ferrucci L, Baroni M, Ranchelli A et al (2014) Interaction between bone and muscle in older persons with mobility limitations. Curr Pharm Des 20(19):3178–3197 Morley JE (2012) Sarcopenia in the elderly. Fam Pract 29(Suppl 1):i44–i48. doi:10.1093/fampra/cmr063.:i44-i48 Bijlsma AY, Meskers CG, Westendorp RG et al (2012) Chronology of age-related disease definitions: osteoporosis and sarcopenia. Ageing Res Rev 11(2):320–324 Staron RS, Leonardi MJ, Karapondo DL et al (1991) Strength and skeletal muscle adaptations in heavy-resistance-trained women after detraining and retraining. J Appl Physiol (1985) 70(2):631–640 Frontera WR, Ochala J (2014) Skeletal muscle: a brief review of structure and function. Calcif Tissue Int 96:183–195 Frost M, Nielsen TL, Brixen K et al (2014) Peak muscle mass in young men and sarcopenia in the ageing male. Osteoporos Int 26:749–756 Schaap LA, Pluijm SM, Deeg DJ et al (2008) Low testosterone levels and decline in physical performance and muscle strength in older men: findings from two prospective cohort studies. Clin Endocrinol (Oxf) 68(1):42–50 El Khoudary SR, McClure CK, VoPham T et al (2014) Longitudinal assessment of the menopausal transition, endogenous sex hormones, and perception of physical functioning: the study of women’s health across the nation. J Gerontol A Biol Sci Med Sci 69(8):1011–1017 Frontera WR, Hughes VA, Fielding RA et al (2000) Aging of skeletal muscle: a 12-yr longitudinal study. J Appl Physiol (1985) 88(4):1321–1326 Goodpaster BH, Park SW, Harris TB et al (2006) The loss of skeletal muscle strength, mass, and quality in older adults: the health, aging and body composition study. J Gerontol A Biol Sci Med Sci 61(10):1059–1064 Visser M, Goodpaster BH, Kritchevsky SB et al (2005) Muscle mass, muscle strength, and muscle fat infiltration as predictors of incident mobility limitations in well-functioning older persons. J Gerontol A Biol Sci Med Sci 60(3):324–333 Isidori AM, Strollo F, More M et al (2000) Leptin and aging: correlation with endocrine changes in male and female healthy adult populations of different body weights. J Clin Endocrinol Metab 85(5):1954–1962 Barbat-Artigas S, Pion CH, Leduc-Gaudet JP et al (2014) Exploring the role of muscle mass, obesity, and age in the relationship between muscle quality and physical function. J Am Med Dir Assoc 15(4):303–320 Stenholm S, Harris TB, Rantanen T et al (2008) Sarcopenic obesity: definition, cause and consequences. Curr Opin Clin Nutr Metab Care. 11(6):693–700 Consensus development conference (1993) diagnosis, prophylaxis, and treatment of osteoporosis. Am J Med 94(6):646–650 Kanis JA, Melton LJ III, Christiansen C et al (1994) The diagnosis of osteoporosis. J Bone Miner Res 9(8):1137–1141 Kanis JA, Johnell O, Oden A et al (2001) Ten year probabilities of osteoporotic fractures according to BMD and diagnostic thresholds. Osteoporos Int 12(12):989–995 Kanis JA, Johnell O, Oden A et al (2008) FRAX and the assessment of fracture probability in men and women from the UK. Osteoporos Int 19(4):385–397 Studenski SA, Peters KW, Alley DE et al (2014) The FNIH sarcopenia project: rationale, study description, conference recommendations, and final estimates. J Gerontol A Biol Sci Med Sci 69(5):547–558 Guralnik JM, Ferrucci L, Pieper CF et al (2000) Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci 55(4):M221–M231 Cesari M, Kritchevsky SB, Penninx BW et al (2005) Prognostic value of usual gait speed in well-functioning older people–results from the health, aging and body composition study. J Am Geriatr Soc 53(10):1675–1680 Studenski S, Perera S, Patel K et al (2011) Gait speed and survival in older adults. JAMA 305(1):50–58 Landi F, Cruz-Jentoft AJ, Liperoti R et al (2013) Sarcopenia and mortality risk in frail older persons aged 80 years and older: results from ilSIRENTE study. Age Ageing 42(2):203–209 Asher L, Aresu M, Falaschetti E et al (2012) Most older pedestrians are unable to cross the road in time: a cross-sectional study. Age Ageing 41(5):690–694 Beavers KM, Beavers DP, Houston DK et al (2013) Associations between body composition and gait-speed decline: results from the health, aging, and body composition study. Am J Clin Nutr 97(3):552–560 Chen LK, Liu LK, Woo J et al (2014) Sarcopenia in Asia: consensus report of the asian working group for sarcopenia. J Am Med Dir Assoc 15(2):95–101 Zeng P, Wu S, Han Y et al (2015) Differences in body composition and physical functions associated with sarcopenia in Chinese elderly: reference values and prevalence. Arch Gerontol Geriatr 60(1):118–123 Alley DE, Shardell MD, Peters KW et al (2014) Grip strength cutpoints for the identification of clinically relevant weakness. J Gerontol A Biol Sci Med Sci 69(5):559–566 Stenholm S, Alley D, Bandinelli S et al (2009) The effect of obesity combined with low muscle strength on decline in mobility in older persons: results from the InCHIANTI study. Int J Obes (Lond). 33(6):635–644 McLean RR, Shardell MD, Alley DE et al (2014) 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. J Gerontol A Biol Sci Med Sci 69(5):576–583 Cawthon PM, Peters KW, Shardell MD et al (2014) Cutpoints for low appendicular lean mass that identify older adults with clinically significant weakness. J Gerontol A Biol Sci Med Sci 69(5):567–575 Baumgartner RN, Koehler KM, Gallagher D et al (1998) Epidemiology of sarcopenia among the elderly in New Mexico. Am J Epidemiol 147(8):755–763 Dam TT, Peters KW, Fragala M et al (2014) An evidence-based comparison of operational criteria for the presence of sarcopenia. J Gerontol A Biol Sci Med Sci 69(5):584–590 Gallagher D, Visser M, De Meersman RE et al (1997) Appendicular skeletal muscle mass: effects of age, gender, and ethnicity. J Appl Physiol (1985) 83(1):229–239 Visser M, Kritchevsky SB, Goodpaster BH et al (2002) Leg muscle mass and composition in relation to lower extremity performance in men and women aged 70 to 79: the health, aging and body composition study. J Am Geriatr Soc 50(5):897–904 Scott D, Hayes A, Sanders KM et al (2014) Operational definitions of sarcopenia and their associations with 5-year changes in falls risk in community-dwelling middle-aged and older adults. Osteoporos Int 25(1):187–193 Beaudart C, Reginster JY, Slomian J et al (2014) Estimation of sarcopenia prevalence using various assessment tools. Exp Gerontol 61:31–37 Bischoff-Ferrari HA, Orav JE, Kanis JA et al (2015) Comparative performance of current definitions of sarcopenia against the prospective incidence of falls among community-dwelling seniors age 65 and older. Osteoporos Int 26:2793–2802 Chumlea WC, Cesari M, Evans WJ et al (2011) Sarcopenia: designing phase IIB trials. J Nutr Health Aging 15(6):450–455 Cesari M, Fielding RA, Pahor M et al (2012) Biomarkers of sarcopenia in clinical trials-recommendations from the international working group on sarcopenia. J Cachexia Sarcopenia Muscle 3(3):181–190 Vellas B, Pahor M, Manini T et al (2013) Designing pharmaceutical trials for sarcopenia in frail older adults: EU/US Task Force recommendations. J Nutr Health Aging 17(7):612–618 Pahor M, Guralnik JM, Ambrosius WT et al (2014) Effect of structured physical activity on prevention of major mobility disability in older adults: the LIFE study randomized clinical trial. JAMA 311(23):2387–2396 Papanicolaou DA, Ather SN, Zhu H et al (2013) A phase IIA randomized, placebo-controlled clinical trial to study the efficacy and safety of the selective androgen receptor modulator (SARM), MK-0773 in female participants with sarcopenia. J Nutr Health Aging 17(6):533–543 Cherubini A, Del-Signore S, Ouslander J et al (2010) Fighting against age discrimination in clinical trials. J Am Geriatr Soc 58(9):1791–1796 Beasley JM, Shikany JM, Thomson CA (2013) The role of dietary protein intake in the prevention of sarcopenia of aging. Nutr Clin Pract 28(6):684–690 Mithal A, Bonjour JP, Boonen S et al (2013) Impact of nutrition on muscle mass, strength, and performance in older adults. Osteoporos Int 24(5):1555–1566 Guralnik JM, Simonsick EM, Ferrucci L et al (1994) A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol 49(2):M85–M94 Savva GM, Donoghue OA, Horgan F et al (2013) Using timed up-and-go to identify frail members of the older population. J Gerontol A Biol Sci Med Sci 68(4):441–446 Cerreta F, Eichler HG, Rasi G (2012) Drug policy for an aging population—the European medicines agency’s geriatric medicines strategy. N Engl J Med 367(21):1972–1974 Fielding RA, Rejeski WJ, Blair S et al (2011) The lifestyle interventions and independence for elders study: design and methods. J Gerontol A Biol Sci Med Sci 66(11):1226–1237 Rolland YM, Cesari M, Miller ME et al (2004) Reliability of the 400-m usual-pace walk test as an assessment of mobility limitation in older adults. J Am Geriatr Soc 52(6):972–976 Lebrasseur NK, Bhasin S, Miciek R et al (2008) Tests of muscle strength and physical function: reliability and discrimination of performance in younger and older men and older men with mobility limitations. J Am Geriatr Soc 56(11):2118–2123 Barbat-Artigas S, Rolland Y, Cesari M et al (2013) Clinical relevance of different muscle strength indexes and functional impairment in women aged 75 years and older. J Gerontol A Biol Sci Med Sci 68(7):811–819 Hicks GE, Shardell M, Alley DE et al (2012) Absolute strength and loss of strength as predictors of mobility decline in older adults: the InCHIANTI study. J Gerontol A Biol Sci Med Sci 67(1):66–73 Bautmans I, Njemini R, Predom H et al (2008) Muscle endurance in elderly nursing home residents is related to fatigue perception, mobility, and circulating tumor necrosis factor-alpha, interleukin-6, and heat shock protein 70. J Am Geriatr Soc 56(3):389–396 Vestergaard S, Nayfield SG, Patel KV et al (2009) Fatigue in a representative population of older persons and its association with functional impairment, functional limitation, and disability. J Gerontol A Biol Sci Med Sci 64(1):76–82 Kent-Braun JA, Callahan DM, Fay JL et al (2014) Muscle weakness, fatigue, and torque variability: effects of age and mobility status. Muscle Nerve 49(2):209–217 Appelboom G, Camacho E, Abraham ME et al (2014) Smart wearable body sensors for patient self-assessment and monitoring. Arch Public Health. 72(1):28–72 Buckinx F, Beaudart C, Slomian J et al (2014) Added value of a triaxial accelerometer assessing gait parameters to predict falls and mortality among nursing home residents: a two-year prospective study. Technol Health Care 23:195–203 Puts MT, Shekary N, Widdershoven G et al (2007) What does quality of life mean to older frail and non-frail community-dwelling adults in the Netherlands? Qual Life Res 16(2):263–277 Ware JE Jr, Sherbourne CD (1992) The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 30(6):473–483 Sayer AA, Syddall HE, Martin HJ et al (2006) Is grip strength associated with health-related quality of life? Findings from the Hertfordshire cohort study. Age Ageing 35(4):409–415 Beaudart C, Reginster JY, Petermans J et al (2015) Quality of life and physical components linked to sarcopenia: the SarcoPhAge study. Exp Gerontol 69:103–110 EuroQol Group (1990) EuroQol—a new facility for the measurement of health-related quality of life. Health Policy 16(3):199–208 Felson DT, Anderson JJ, Boers M et al (1993) The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. The committee on outcome measures in rheumatoid arthritis clinical trials. Arthritis Rheum 36(6):729–740 Kirkham JJ, Boers M, Tugwell P et al (2013) Outcome measures in rheumatoid arthritis randomised trials over the last 50 years. Trials 14:324 Core Outcome Measures in Effectiveness Trials (COMET). http://www.comet-initiative.org/. Accessed 21 Nov 2014 Boers M, Idzerda L, Kirwan JR et al (2014) Toward a generalized framework of core measurement areas in clinical trials: a position paper for OMERACT 11. J Rheumatol 41(5):978–985 Fried LP, Tangen CM, Walston J et al (2001) Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci 56(3):M146–M156 Lawton MP (1971) The functional assessment of elderly people. J Am Geriatr Soc 19(6):465–481 European Innovation Partnership on Active and Healthy Ageing. A Europe 2020 Initiative. http://ec.europa.eu/research/innovation-union/index_en.cfm?section=active-healthy-ageing. Accessed 21 Nov 2014 AginginMotion.org. http://aginginmotion.org/. Accessed 19 Nov 2014 Beaudart C, Rizzoli R, Bruyere O et al (2014) Sarcopenia: burden and challenges for public health. Arch Public Health 72(1):45 Janssen I, Shepard DS, Katzmarzyk PT et al (2004) The healthcare costs of sarcopenia in the United States. J Am Geriatr Soc 52(1):80–85 Fairhall N, Sherrington C, Lord SR et al (2014) Effect of a multifactorial, interdisciplinary intervention on risk factors for falls and fall rate in frail older people: a randomised controlled trial. Age Ageing 43(5):616–622 Romero-Ortuno R, O’Shea D (2013) Fitness and frailty: opposite ends of a challenging continuum! Will the end of age discrimination make frailty assessments an imperative? Age Ageing 42(3):279–280 Kanis JA, McCloskey EV, Johansson H et al (2013) European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporos Int 24(1):23–57