Effects of recombinant human growth hormone for 1 year on body composition and muscle strength in children on long-term steroid therapy: randomized controlled, delayed-start study

J Clin Endocrinol Metab. 2013 Jul;98(7):2746-54. doi: 10.1210/jc.2012-4201. Epub 2013 Apr 26.

Abstract

Context: Recombinant human GH (rhGH) improves growth and body composition in glucocorticoid-treated children. Its effects on muscle strength are poorly evaluated.

Objectives: Our objective was to evaluate rhGH effects on muscle strength in children receiving long-term glucocorticoid therapy; effects on height SD score (SDS) and body composition were assessed also.

Design and setting: A randomized, controlled, delayed-start study of rhGH for 12 months was started after randomization (baseline) or 6 months later (M6).

Patients: Patients included 30 children with various diagnoses.

Intervention: rhGH was administered at 0.065 mg/kg/d for 6 months and then in the dosage maintaining serum IGF-I levels below +2 SDS for chronological age.

Main outcome measures: The primary criterion was the between-group difference in composite index of muscle strength (CIMS) change at M6. Secondary criteria included between-group differences in CIMS SDS(height), lean mass (LM), thigh muscle area (MA), and height SDS changes at M6; these parameters were also assessed in the overall population after 1 year of rhGH therapy.

Results: At M6, rhGH therapy did not significantly affect changes in CIMS or CIMS SDS(height) (+17.6% vs +7.5% and +0.14 ± 0.38 vs +0.11 ± 0.62, respectively); the rhGH-treated group had significantly larger changes in height SDS (+0.2 [0.3] vs -0.2 [0.3]; P = 0.003), LM (+7.3% [+3.7%; +21.6%] vs 0% [-4.7%; +3.2%]; P = 0.002), and MA (+8.8% [+5%; +15.6%] vs. -0.6% [-6.3%; +7.7%]; P = 0.01) compared with the untreated group. After 1 year of rhGH, height SDS, LM, and MA increased significantly, CIMS increased by 24.7% (+5.8%; +34.2%), and CIMS SDS(height) remained within the normal range.

Conclusions: rhGH increased height, LM, and MA. However, muscle strength did not improve significantly.

Publication types

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

MeSH terms

  • Adolescent
  • Adolescent Development / drug effects*
  • Body Composition / drug effects*
  • Body Height / drug effects
  • Child
  • Child Development / drug effects*
  • Chronic Disease / drug therapy*
  • Drug Monitoring
  • Female
  • Follow-Up Studies
  • Glucocorticoids / adverse effects*
  • Glucocorticoids / therapeutic use
  • Growth Disorders / chemically induced
  • Growth Disorders / etiology
  • Growth Disorders / prevention & control
  • Human Growth Hormone / administration & dosage
  • Human Growth Hormone / adverse effects
  • Human Growth Hormone / therapeutic use*
  • Humans
  • Insulin-Like Growth Factor I / analysis
  • Male
  • Muscle Strength / drug effects*
  • Muscle Weakness / etiology
  • Muscle Weakness / prevention & control
  • Pilot Projects
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / adverse effects
  • Recombinant Proteins / therapeutic use

Substances

  • Glucocorticoids
  • Recombinant Proteins
  • Human Growth Hormone
  • Insulin-Like Growth Factor I