Efficacy of a long-acting growth hormone (GH) preparation in patients with adult GH deficiency

J Clin Endocrinol Metab. 2005 Dec;90(12):6431-40. doi: 10.1210/jc.2005-0928. Epub 2005 Sep 13.

Abstract

Context: Treatment of adult GH deficiency (AGHD) with daily injections of GH results in decreased adipose mass, increased lean body mass (LBM), increased bone mineral density, and improved quality of life.

Objective: This study seeks to determine whether a depot preparation of GH given every 14 d would lead to comparable decreases in trunk adipose tissue as daily GH.

Design: This open-label, randomized study compares subjects receiving depot GH, daily GH, or no therapy.

Setting: The study was performed at 23 university or local referral endocrine centers.

Patients or other participants: One hundred thirty-five adults with AGHD syndrome participated in the study.

Intervention: Subjects were randomized to receive depot GH (n = 51), daily GH (n = 53), or no treatment (n = 31) for 32 wk. The dose of GH was titrated so that IGF-I was less than or equal to +2 SD of the age-adjusted normal range.

Main outcome measure: Trunk adipose tissue was the main outcome measure as measured by dual energy x-ray absorptiometry.

Results: The percentage of the trunk region that is fat increased by 0.4 in the no treatment group, but decreased by 3.2 (P = 0.001 vs. untreated) in the GH depot group and by 2.5 (P < 0.004 vs. untreated) in the daily GH group. Visceral adipose tissue area decreased by 9.1% in the GH depot group and by 6.8% in the daily GH group. LBM and high-density lipoprotein increased in both treatment groups. Side effect profiles were similar. Three subjects receiving GH experienced serious episodes of adrenal insufficiency.

Conclusions: GH diminishes trunk and visceral adipose tissue and increases LBM in AGHD. A depot form of GH that is administered every 14 d is as safe and effective as daily GH injections.

Publication types

  • Clinical Trial, Phase II
  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Age of Onset
  • Body Composition / drug effects
  • C-Reactive Protein / metabolism
  • Delayed-Action Preparations
  • Drug Administration Schedule
  • Female
  • Human Growth Hormone / administration & dosage*
  • Human Growth Hormone / adverse effects
  • Human Growth Hormone / deficiency*
  • Human Growth Hormone / therapeutic use
  • Humans
  • Injections, Subcutaneous
  • Insulin-Like Growth Factor I / metabolism
  • Lipids / blood
  • Male
  • Middle Aged
  • Sex Characteristics
  • Steroid Metabolism, Inborn Errors / blood
  • Steroid Metabolism, Inborn Errors / diagnostic imaging
  • Steroid Metabolism, Inborn Errors / drug therapy*
  • Steroid Metabolism, Inborn Errors / epidemiology
  • Tomography, X-Ray Computed

Substances

  • Delayed-Action Preparations
  • Lipids
  • Human Growth Hormone
  • Insulin-Like Growth Factor I
  • C-Reactive Protein