title: Efficacy and safety of Samtropin™ recombinant human growth hormone; a double-blind randomized clinical trial.
abstract: BACKGROUND
  Recombinant human growth hormone (rhGH) can increase the growth rate in growth hormone deficient children (GHD). In this randomized clinical trial, we compared the efficacy and side effects of an Iranian brand; Samtropin with Norditropin.
  
  
  METHODS
  The GHD children were randomly treated either with standard dose of Samtropin or Norditropin rhGH for one year. Upstanding height, height standard deviation score (HSDS), growth velocity (GV), serum levels of insulin like growth factor-1 (IGF-1), and bone age (BA) were determined before and during one year treatment concomitant side effects of treatment.
  
  
  RESULTS
  We evaluated 22 subjects; 12 on Samtropin and, 10 on Norditropin. In each group, mean age was 12 yr and 50% of them were male. The mean differences in height, HSDS, IGF-1 and BA by Norditropin before and after 12 months were 8.8 cm, 0.5, 49 ng/ml and 2.8 yr, respectively. These measures by Samtropin were 9.1 cm, 0.6, 133 ng/ml, and 1.7 yr, respectively without any significant difference. The mean of GV by Samtropin was 9.1 vs. 8.8 cm by Norditropin without significant difference. Since the efficacy of Samtropin was found to be similar to Norditropin after 12 months; we switched to use only Samtropin for the next 12 months. The mean differences in height, HSDS, GV and BA in 20 children between months 12 and 24 were 7.0 cm, 1.6, 2.1 cm/yr and 1.0 yr, respectively (P < 0.001). We also found a non-significant decrease in IGF-1 levels. No side effects were observed.
  
  
  CONCLUSIONS
  We need to conduct a post marketing surveillance with a large sample size in order to confirm our findings.
  
  
  BACKGROUND
  Registration code number in the Iranian Registry of Clinical Trials (IRCT): IRCT1138901181414N11.
authors: Endocrinology & Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran ; Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors: Ozra
authors: O
authors: Tabatabaei-Malazy
authors: Endocrinology & Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors: Mohammad Reza
authors: MR
authors: Mohajeri-Tehrani
authors: Chronic Diseases Research Center, Endocrinology and Metabolism Population Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors: Ramin
authors: R
authors: Heshmat
authors: Endocrinology & Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors: Eghbal
authors: E
authors: Taheri
authors: Chronic Diseases Research Center, Endocrinology and Metabolism Population Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors: Gita
authors: G
authors: Shafiee
authors: Inborn Error of Metabolism Research Center, Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors: Maryam
authors: M
authors: Razzaghy-Azar
authors: Growth & Development Center, Tehran University of Medical Sciences, Tehran, Iran ; Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
authors: Ali
authors: A
authors: Rabbani
authors: Department of Public Health, Alborz University of Medical Sciences, Karaj, Iran ; Non-Communicable Diseases Research Center, Endocrinology and Metabolism Population Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors: Mostafa
authors: M
authors: Qorbani
authors: Endocrinology & Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors: Hossein
authors: H
authors: Adibi
authors: Endocrinology & Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors: Samimeh
authors: S
authors: Shahbazi
authors: Endocrinology & Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors: Farzaneh
authors: F
authors: Karimi
authors: Endocrinology & Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors: Sheema
authors: S
authors: Rezaian
authors: Endocrinology & Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors: Bagher
authors: B
authors: Larijani
keywords: Children; Growth hormone deficiency; Insulin like growth factor-1; Recombinant human growth hormone
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