title: Dose-dependent effect of growth hormone on final height in children with short stature without growth hormone deficiency.
abstract: BACKGROUND
  The effect of GH therapy in short non-GH-deficient children, especially those with idiopathic short stature (ISS), has not been clearly established owing to the lack of controlled trials continuing until final height (FH).
  
  
  OBJECTIVE
  The aim of the study was to investigate the effect on growth to FH of two GH doses given to short children, mainly with ISS, compared with untreated controls.
  
  
  METHODS
  A randomized, controlled, long-term multicenter trial was conducted in Sweden.
  
  
  METHODS
  Two doses of GH (Genotropin) were administered, 33 or 67 microg/kg.d; control subjects were untreated.
  
  
  METHODS
  A total of 177 subjects with short stature were enrolled. Of these, 151 were included in the intent to treat (AllITT) population, and 108 in the per protocol (AllPP) population. Analysis of ISS subjects included 126 children in the ITT (ISSITT) population and 68 subjects in the PP (ISSPP) population.
  
  
  METHODS
  We measured FH sd score (SDS), difference in SDS to midparenteral height (diff MPHSDS), and gain in heightSDS.
  
  
  RESULTS
  After 5.9+/-1.1 yr on GH therapy, the FHSDS in the AllPP population treated with GH vs. controls was -1.5+/-0.81 (33 microg/kg.d, -1.7+/-0.70; and 67 microg/kg.d, -1.4+/-0.86; P<0.032), vs. -2.4+/-0.85 (P<0.001); the diff MPHSDS was -0.2+/-1.0 vs. -1.0+/-0.74 (P<0.001); and the gain in heightSDS was 1.3+/-0.78 vs. 0.2+/-0.69 (P<0.001). GH therapy was safe and had no impact on time to onset of puberty. A dose-response relationship identified after 1 yr remained to FH for all growth outcome variables in all four populations.
  
  
  CONCLUSIONS
  GH treatment significantly increased FH in ISS children in a dose-dependent manner, with a mean gain of 1.3 SDS (8 cm) and a broad range of response from no gain to 3 SDS compared to a mean gain of 0.2 SDS in the untreated controls.
authors: Göteborg Pediatric Growth Research Center/Växthuset, Department of Pediatrics, The Sahlgrenska Academy at University of Gothenburg, and The Queen Silvia Children's Hospital, Göteborg, Sweden. kerstin.albertsson-wikland@pediat.gu.se
authors: Kerstin
authors: K
authors: Albertsson-Wikland
authors: A Stefan
authors: AS
authors: Aronson
authors: Jan
authors: J
authors: Gustafsson
authors: Lars
authors: L
authors: Hagenäs
authors: Sten A
authors: SA
authors: Ivarsson
authors: Björn
authors: B
authors: Jonsson
authors: Berit
authors: B
authors: Kriström
authors: Claude
authors: C
authors: Marcus
authors: Karl Olof
authors: KO
authors: Nilsson
authors: E Martin
authors: EM
authors: Ritzén
authors: Torsten
authors: T
authors: Tuvemo
authors: Otto
authors: O
authors: Westphal
authors: Jan
authors: J
authors: Aman
mesh_terms: D000328:Adult; D001827:Body Height / Q000187:drug effects*; D015992:Body Mass Index; D002648:Child; D004392:Dwarfism / Q000188:drug therapy*; D005260:Female; D006130:Growth Disorders / Q000188:drug therapy; D019382:Human Growth Hormone / Q000008:administration & dosage / Q000494:pharmacology* / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D010290:Parents; D018579:Patient Selection; D011627:Puberty; D013548:Sweden; D016896:Treatment Outcome
chemical_list: D019382:Human Growth Hormone