Growth hormone (GH) replacement therapy in adult-onset gh deficiency: effects on body composition in men and women in a double-blind, randomized, placebo-controlled trial

J Clin Endocrinol Metab. 2004 May;89(5):2048-56. doi: 10.1210/jc.2003-030346.

Abstract

Adult GH deficiency (AGHD) is characterized by an altered body composition, an atherogenic lipid profile, decreased exercise capacity, and diminished quality of life. We performed a randomized, double-blind, placebo-controlled, multicenter study in 166 subjects with AGHD to assess the effects of GH on these outcomes. GH was initiated at 0.0125 mg/kg.d, increased to 0.025 mg/kg.d as tolerated, or decreased to 0.00625 mg/kg.d for 12 months. Primary measures of efficacy included body composition, strength and endurance, and quality of life. Additional parameters included serum IGF-I concentrations, serum lipids, and bone mineral density. After 12 months, 79% of subjects remained on GH 0.0125 mg/kg.d, whereas 21% received 0.00625 mg/kg.d. GH-treated men and women demonstrated significant decreases in total body and trunk fat and increases in lean body mass over baseline. In GH-treated men, mean IGF-I SD scores exceeded age-adjusted normal ranges, whereas similar doses produced a smaller response in women. GH treatment was associated with significant improvements in total cholesterol and low-density lipoprotein (P < 0.05 for all). No significant treatment effects were observed in strength and endurance, quality of life, or bone mineral density. GH treatment was generally well tolerated. Subjects with AGHD should receive individualized GH therapy to maintain IGF-I between the mean value and +2 SD and improve body composition and cardiovascular risk factors.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Anthropometry
  • Body Composition / drug effects*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Human Growth Hormone / administration & dosage
  • Human Growth Hormone / adverse effects
  • Human Growth Hormone / deficiency*
  • Human Growth Hormone / therapeutic use*
  • Humans
  • Insulin-Like Growth Factor I / metabolism
  • Lipids / blood
  • Male
  • Metabolism, Inborn Errors / drug therapy
  • Metabolism, Inborn Errors / pathology
  • Metabolism, Inborn Errors / physiopathology
  • Middle Aged
  • Muscle, Skeletal / physiopathology
  • Physical Endurance
  • Placebos
  • Quality of Life
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / adverse effects
  • Recombinant Proteins / therapeutic use

Substances

  • Lipids
  • Placebos
  • Recombinant Proteins
  • Human Growth Hormone
  • Insulin-Like Growth Factor I