title: Durability of the effects of testosterone and growth hormone supplementation in older community-dwelling men: the HORMA Trial.
abstract: OBJECTIVE
  To determine the durability of anabolic effects and adverse events (AEs) after stopping testosterone and growth hormone supplementation in older men.
  
  
  METHODS
  Secondary analysis of a double-masked, randomized controlled trial of testosterone gel (5 or 10 g/daily) plus rhGH (0, 3 or 5 μg/kg/day) with follow-up of outcomes 3 months later.
  
  
  METHODS
  A total of 108 community-dwelling 65- to 90-year-old men.
  
  
  METHODS
  Testosterone and IGF-1 levels, body composition (DEXA), 1-repetition maximum (1-RM) strength, stair-climbing power, quality-of-life (QOL) and activity questionnaires, AEs.
  
  
  RESULTS
  Despite improvements in body composition during treatment, residual benefits 3 months later (week 28) were variable. For participants with improvements exceeding their week-17 median changes, benefits were sustained at week 28 for lean body mass (1·45 ± 1·63 kg, 45% of week-17 values, P < 0·0001 vs baseline), appendicular skeletal muscle mass (ASMM, 0·71 ± 1·01 kg, 42%, P < 0·0001), total fat (-1·06 ± 2·18 kg, 40%, P < 0·0001) and trunk fat (-0·89 ± 1·42 kg, 50%, P < 0·0001); retention of ASMM was associated with greater week-16 protein intake (P = 0·01). For 1-RM strength, 39%-43% of week-17 improvements (P ≤ 0·05) were retained and associated with better week-17 strength (P < 0·0001), change in testosterone from week 17-to 28 (P = 0·004) and baseline PASE (P = 0·04). Framingham 10-year cardiovascular risks were low (~14%), did not worsen and improved by week 28 (P = 0·0002). The hypothalamic-pituitary-gonadal axis recovered completely.
  
  
  CONCLUSIONS
  Durable improvements in muscle mass, strength and fat mass were retained 3 months after discontinuing hormone supplementation in participants with greater than median body composition changes during treatment, but not in others with smaller gains. AEs largely resolved after intervention discontinuation. Additional strategies may be needed to sustain or augment muscle mass and strength gains achieved during short-term hormone therapy.
authors.affiliation: Department of Medicine, University of Southern CaliforniaDivision of Biokinesiology, University of Southern California, Los Angeles, CASection of Endocrinology, Diabetes, and Nutrition, Boston University, Boston, MADepartment of Preventive Medicine, University of Southern California, Los Angeles, CADepartment of Medicine, Washington University, St Louis, MOJean Mayer USDA Human Nutrition Research Center on Aging of Tufts University, Boston, MADepartment of Urology, University of Southern California, Los Angeles, CA, USA.
authors.forename: Fred R
authors.initials: FR
authors.lastname: Sattler
authors.forename: Shalender
authors.initials: S
authors.lastname: Bhasin
authors.forename: Jiaxiu
authors.initials: J
authors.lastname: He
authors.forename: Kevin E
authors.initials: KE
authors.lastname: Yarasheski
authors.forename: Ellen F
authors.initials: EF
authors.lastname: Binder
authors.forename: E Todd
authors.initials: ET
authors.lastname: Schroeder
authors.forename: Carmen
authors.initials: C
authors.lastname: Castaneda-Sceppa
authors.forename: Miwa
authors.initials: M
authors.lastname: Kawakubo
authors.forename: Ronenn
authors.initials: R
authors.lastname: Roubenoff
authors.forename: Matthew
authors.initials: M
authors.lastname: Dunn
authors.forename: Chris
authors.initials: C
authors.lastname: Hahn
authors.forename: Yolanda
authors.initials: Y
authors.lastname: Stewart
authors.forename: Carmen
authors.initials: C
authors.lastname: Martinez
authors.forename: Stanley P
authors.initials: SP
authors.lastname: Azen
mesh_terms: D000368:Aged; D045930:Anabolic Agents; D019587:Dietary Supplements; D004311:Double-Blind Method; D019382:Human Growth Hormone / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D006801:Humans; D008297:Male; D013739:Testosterone / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D016896:Treatment Outcome
chemical_list: D045930:Anabolic Agents; D019382:Human Growth Hormone; D013739:Testosterone