title: Growth hormone (GH) treatment to final height in children with idiopathic short stature: evidence for a dose effect.
abstract: OBJECTIVE
  To investigate in an open-label randomized study, the effect of two doses of growth hormone (GH) on final height and height velocity during the first 2 years of treatment of children with idiopathic short stature (mean baseline height standard deviation score [SDS] -3.2).
  
  
  METHODS
  Patients were treated with GH at 0.24 mg/kg/week, 0.24 mg/kg/week for the first year and at 0.37 mg/kg/week thereafter (0.24-->0.37), or 0.37 mg/kg/week. Final height was evaluated in 50 patients at study completion (mean treatment duration, 6.5 years).
  
  
  RESULTS
  Patients who received 0.37 mg/kg/week (n = 72) experienced a significantly greater increase in height velocity than those who received 0.24 mg/kg/week (n = 70) (treatment difference = 0.8 cm/year; P = .003) or 0.24-->0.37 mg/kg/week (n = 67) (treatment difference = 0.9 cm/year; P = .001). For the 50 patients for whom final height measurements were available, mean height SDS increased by 1.55, 1.52, and 1.85 SDS, respectively, for the three dose groups. For the primary comparison between the 0.37 mg/kg/week and 0.24 mg/kg/week dose groups, the mean treatment difference (adjusted for differences in baseline predicted height SDS) was 0.57 SDS (3.6 cm; P = .025). Mean overall height gains (final height minus baseline predicted height) were 7.2 cm and 5.4 cm for the 0.37 mg/kg/week and 0.24 mg/kg/week dose groups, respectively, without dose effects on safety parameters. Final height measurements were within the normal adult height range for 94% of patients randomized to 0.37 mg/kg/week who continued to final height.
  
  
  CONCLUSIONS
  GH treatment dose-dependently increases height velocity and final height in children with idiopathic short stature.
authors.affiliation: Leiden University Medical Center, Leiden, the Netherlands. j.m.wit@lumc.nl
authors.forename: Jan M
authors.initials: JM
authors.lastname: Wit
authors.forename: Lyset T M
authors.initials: LT
authors.lastname: Rekers-Mombarg
authors.forename: Gordon B
authors.initials: GB
authors.lastname: Cutler
authors.forename: Brenda
authors.initials: B
authors.lastname: Crowe
authors.forename: Tracy J
authors.initials: TJ
authors.lastname: Beck
authors.forename: Kristen
authors.initials: K
authors.lastname: Roberts
authors.forename: Anne
authors.initials: A
authors.lastname: Gill
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Chaussain
authors.forename: Herwig
authors.initials: H
authors.lastname: Frisch
authors.forename: Rafael
authors.initials: R
authors.lastname: Yturriaga
authors.forename: Andrea F
authors.initials: AF
authors.lastname: Attanasio
mesh_terms: D000293:Adolescent; D000365:Age Determination by Skeleton; D001827:Body Height / Q000187:drug effects*; D001846:Bone Development / Q000187:drug effects; D002648:Child; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006130:Growth Disorders / Q000188:drug therapy*; D019382:Human Growth Hormone / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D011994:Recombinant Proteins / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; D019382:Human Growth Hormone