naa a22 4500 510785816 CHVBK 20180411083301.0 cr unu---uuuuu 180411e20130601xx s 000 0 eng 10.1007/s12603-013-0335-x doi (NATIONALLICENCE)springer-10.1007/s12603-013-0335-x 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 [Elektronische Daten] [Dimitris Papanicolaou, S. Ather, H. Zhu, Y. Zhou, J. Lutkiewicz, B. Scott, J. Chandler] Background: Sarcopenia, the age-related loss of muscle mass [defined as appendicular LBM/Height2 (aLBM/ht2) below peak value by>1SD], strength and function, is a major contributing factor to frailty in the elderly. MK-0773 is a selective androgen receptor modulator designed to improve muscle function while minimizing effects on other tissues. Objectives: The primary objective of this study was to demonstrate an improvement in muscle strength and lean body mass (LBM) in sarcopenic frail elderly women treated with MK-0773 relative to placebo. Design: This was a randomized, double-blind, parallel-arm, placebo-controlled, multicenter, 6-month study. Participants were randomized in a 1:1 ratio to receive either MK-0773 50mg b.i.d. or placebo; all participants received Vitamin D and protein supplementation. Setting: General community. Participants: 170 Women aged ≥65 with sarcopenia and moderate physical dysfunction. Measurements: Dual energy X-ray absorptiometry, muscle strength and power, physical performance measures. Results: Participants receiving MK-0773 showed a statistically significant increase in LBM from baseline at Month 6 vs. placebo (p<0.001). Participants receiving both MK-0773 and placebo showed a statistically significant increase in strength from baseline to Month 6, but the mean difference between the two groups was not significant (p=0.269). Both groups showed significant improvement from baseline at Month 6 in physical performance measures, but there were no statistically significant differences between participants receiving MK-0773 and placebo. A greater number of participants experienced elevated transaminases in the MK-0773 group vs. placebo, which resolved after discontinuation of study therapy. MK-0773 was generally well-tolerated with no evidence of androgenization. Conclusions: The MK-0773-induced increase in LBM did not translate to improvement in strength or function vs. placebo. The improvement of strength and physical function in the placebo group could be at least partly attributed to protein and vitamin D supplementation. Serdi and Springer-Verlag France, 2013 Sarcopenia nationallicence aging nationallicence lean body mass nationallicence muscle nationallicence selective androgen receptor modulator nationallicence Papanicolaou Dimitris Merck Sharp & Dohme Corp., P.O. Box 100, 08889, Whitehouse Station, NJ, USA aut Ather S. Merck Sharp & Dohme Corp., P.O. Box 100, 08889, Whitehouse Station, NJ, USA aut Zhu H. Merck Sharp & Dohme Corp., P.O. Box 100, 08889, Whitehouse Station, NJ, USA aut Zhou Y. Merck Sharp & Dohme Corp., P.O. Box 100, 08889, Whitehouse Station, NJ, USA aut Lutkiewicz J. Merck Sharp & Dohme Corp., P.O. Box 100, 08889, Whitehouse Station, NJ, USA aut Scott B. Merck Sharp & Dohme Corp., P.O. Box 100, 08889, Whitehouse Station, NJ, USA aut Chandler J. Merck Sharp & Dohme Corp., P.O. Box 100, 08889, Whitehouse Station, NJ, USA aut The journal of nutrition, health & aging Springer Paris 17/6(2013-06-01), 533-543 1279-7707 17:6<533 2013 17 12603 https://doi.org/10.1007/s12603-013-0335-x text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s12603-013-0335-x text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Papanicolaou Dimitris Merck Sharp & Dohme Corp., P.O. Box 100, 08889, Whitehouse Station, NJ, USA aut NATIONALLICENCE 700 1- Ather S. Merck Sharp & Dohme Corp., P.O. Box 100, 08889, Whitehouse Station, NJ, USA aut NATIONALLICENCE 700 1- Zhu H. Merck Sharp & Dohme Corp., P.O. Box 100, 08889, Whitehouse Station, NJ, USA aut NATIONALLICENCE 700 1- Zhou Y. Merck Sharp & Dohme Corp., P.O. Box 100, 08889, Whitehouse Station, NJ, USA aut NATIONALLICENCE 700 1- Lutkiewicz J. Merck Sharp & Dohme Corp., P.O. Box 100, 08889, Whitehouse Station, NJ, USA aut NATIONALLICENCE 700 1- Scott B. Merck Sharp & Dohme Corp., P.O. Box 100, 08889, Whitehouse Station, NJ, USA aut NATIONALLICENCE 700 1- Chandler J. Merck Sharp & Dohme Corp., P.O. Box 100, 08889, Whitehouse Station, NJ, USA aut NATIONALLICENCE 773 0- The journal of nutrition, health & aging Springer Paris 17/6(2013-06-01), 533-543 1279-7707 17:6<533 2013 17 12603 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer