title: Long-term safety and efficacy of the recombinant human growth hormone Omnitrope® in the treatment of Spanish growth hormone deficient children: results of a phase III study.
abstract: BACKGROUND
  This phase III study in growth hormone (GH) deficient (GHD) children with growth retardation was designed to demonstrate the safety and efficacy of longterm treatment with the recombinant human GH Omnitrope® (Sandoz BioPharmaceuticals, Holzkirchen, Germany).
  
  
  METHODS
  Treatment-naïve, prepubertal Spanish children (n=70) with isolated GHD were treated with Omnitrope 0.03 mg/kg/day subcutaneously. Changes in height, height standard deviation score (HSDS), height velocity (HV), HV standard deviation score (HVSDS), serum insulin-like growth factor (IGF)-1, and insulin-like growth factor binding protein (IGFBP)-3 levels were recorded.
  
  
  RESULTS
  Omnitrope treatment provided a good growth response after 4 years, shown by a significant increase in mean body height (31.1 cm [95% CI: 29.6-32.6]), HSDS (Tanner) (1.42 [1.13-1.70]), HV (2.4 cm [1.7-3.1]), and HVSDS values (3.5 [2.7-4.3]). Mean IGF-1 and IGFBP-3 serum levels also increased significantly.
  
  
  CONCLUSIONS
  At a dose of 0.03 mg/kg/day, Omnitrope was safe, effective, and well tolerated during long-term treatment of children with GHD.
authors.affiliation: Pediatrics Department, Carlos Haya Hospital, Málaga, Spain.
authors.forename: J
authors.initials: J
authors.lastname: López-Siguero
authors.forename: Ma Victoria
authors.initials: MV
authors.lastname: Borrás Pérez
authors.forename: S
authors.initials: S
authors.lastname: Balser
authors.forename: J
authors.initials: J
authors.lastname: Khan-Boluki
mesh_terms: D059451:Biosimilar Pharmaceuticals; D001827:Body Height / Q000187:drug effects; D002648:Child; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions; D004393:Dwarfism, Pituitary / Q000188:drug therapy*; D005260:Female; D019382:Human Growth Hormone / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006801:Humans; D018972:Insulin-Like Growth Factor Binding Protein 3 / Q000097:blood / Q000187:drug effects; D007334:Insulin-Like Growth Factor I / Q000187:drug effects / Q000378:metabolism; D008297:Male; D011994:Recombinant Proteins / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D013030:Spain
chemical_list: D059451:Biosimilar Pharmaceuticals; D018972:Insulin-Like Growth Factor Binding Protein 3; D011994:Recombinant Proteins; D019382:Human Growth Hormone; D007334:Insulin-Like Growth Factor I