title: 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.
abstract: BACKGROUND
  Recombinant human GH (rhGH) improves growth and body composition in glucocorticoid-treated children. Its effects on muscle strength are poorly evaluated.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  A randomized, controlled, delayed-start study of rhGH for 12 months was started after randomization (baseline) or 6 months later (M6).
  
  
  METHODS
  Patients included 30 children with various diagnoses.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
authors.affiliation: Assistance Publique-Hôpitaux de Paris, Hôpital Robert Debré, Service d'Endocrinologie Pédiatrique, 75019 Paris, France. dominique.simon@rdb.aphp.fr
authors.forename: Dominique
authors.initials: D
authors.lastname: Simon
authors.forename: Corinne
authors.initials: C
authors.lastname: Alberti
authors.forename: Marianne
authors.initials: M
authors.lastname: Alison
authors.forename: Loïc
authors.initials: L
authors.lastname: Le Henaff
authors.forename: Didier
authors.initials: D
authors.lastname: Chevenne
authors.forename: Priscilla
authors.initials: P
authors.lastname: Boizeau
authors.forename: Aurélie
authors.initials: A
authors.lastname: Canal
authors.forename: Gwenn
authors.initials: G
authors.lastname: Ollivier
authors.forename: Valérie
authors.initials: V
authors.lastname: Decostre
authors.forename: Evelyne
authors.initials: E
authors.lastname: Jacqz-Aigrain
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Carel
authors.forename: Paul
authors.initials: P
authors.lastname: Czernichow
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Hogrel
mesh_terms: D000293:Adolescent; D041923:Adolescent Development / Q000187:drug effects*; D001823:Body Composition / Q000187:drug effects*; D001827:Body Height / Q000187:drug effects; D002648:Child; D002657:Child Development / Q000187:drug effects*; D002908:Chronic Disease / Q000188:drug therapy*; D016903:Drug Monitoring; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000009:adverse effects* / Q000627:therapeutic use; D006130:Growth Disorders / Q000139:chemically induced / Q000209:etiology / Q000517:prevention & control; D019382:Human Growth Hormone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000032:analysis; D008297:Male; D053580:Muscle Strength / Q000187:drug effects*; D018908:Muscle Weakness / Q000209:etiology / Q000517:prevention & control; D010865:Pilot Projects; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D005938:Glucocorticoids; D011994:Recombinant Proteins; D019382:Human Growth Hormone; D007334:Insulin-Like Growth Factor I