Document Detail

Seven years of safety and efficacy of the recombinant human growth hormone Omnitrope in the treatment of growth hormone deficient children: results of a phase III study.
MedLine Citation:
PMID:  19844125     Owner:  NLM     Status:  MEDLINE    
AIM: This phase III clinical study in growth hormone deficiency (GHD) children with growth retardation was designed to compare efficacy and safety of Omnitrope((R)) with Genotropin((R)) and assess the long-term safety and efficacy of Omnitrope((R)). The results of 7 years of treatment with Omnitrope((R)) are presented. PATIENTS AND METHODS: Eighty-nine treatment-na?ve, prepubertal children with GHD were randomized (part 1) to Omnitrope((R)) lyophilisate (group A, n = 44) or Genotropin((R)) (group B, n = 45) for 9 months and received a subcutaneous dose of 0.03 mg/kg/day. In part 2, patients receiving Omnitrope((R))lyophilisate continued the same treatment for a further 6 months, while patients on Genotropin((R)) were switched to Omnitrope((R)) liquid for the subsequent 6 months. In part 3, patients in both groups received Omnitrope((R))liquid for a period up to 69 months. RESULTS: The development of the 4 auxological parameters (height, height SD score, height velocity and height velocity SD score) and IGF-1 and IGFBP-3 levels were comparable between both groups of patients and confirmed the well-known growth response of GHD children to recombinant human GH treatment. Omnitrope((R)) was well tolerated and safe over 7 years of treatment. CONCLUSION: The clinical comparability between Omnitrope((R)) and Genotropin((R)) was demonstrated within 9 months of treatment. Long-term safety and efficacy of 7 years of treatment with Omnitrope((R)) was proven.
T Romer; P Saenger; F Peter; M Walczak; Y Le Bouc; J Khan-Boluki; A Berghout
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Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial     Date:  2009-10-21
Journal Detail:
Title:  Hormone research     Volume:  72     ISSN:  1423-0046     ISO Abbreviation:  Horm. Res.     Publication Date:  2009  
Date Detail:
Created Date:  2009-12-09     Completed Date:  2010-02-22     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0366126     Medline TA:  Horm Res     Country:  Switzerland    
Other Details:
Languages:  eng     Pagination:  359-69     Citation Subset:  IM    
Department of Endocrinology, Children's Memorial Health Institute, Warsaw, Poland.
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MeSH Terms
Body Height / drug effects
Child, Preschool
Growth Disorders / blood,  drug therapy*,  pathology
Human Growth Hormone / administration & dosage,  adverse effects,  deficiency*,  therapeutic use*
Insulin-Like Growth Factor Binding Proteins / blood
Insulin-Like Growth Factor I / metabolism
Recombinant Proteins / administration & dosage,  adverse effects,  therapeutic use
Treatment Outcome
Weight Gain / drug effects
Reg. No./Substance:
0/IGFBP3 protein, human; 0/Insulin-Like Growth Factor Binding Proteins; 0/Recombinant Proteins; 12629-01-5/Human Growth Hormone; 67763-96-6/Insulin-Like Growth Factor I

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