Abstract
BackgroundRecombinant 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.MethodsThe 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.ResultsWe 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.ConclusionsWe need to conduct a post marketing surveillance with a large sample size in order to confirm our findings.Trial registrationRegistration code number in the Iranian Registry of Clinical Trials (IRCT): IRCT1138901181414N11.
Highlights
Recombinant human growth hormone has been established as an appropriate treatment to increase the growth rate in children with growth hormone deficiency (GHD), Turner syndrome (TS), Prader-Willi syndrome (PWS), chronic renal failure (CRF), and being born smallIt is shown that rhGH could improve the linear growth partly through stimulation of the production of insulin like growth factor-1 (IGF-1) [9]
There were no significant differences in baseline characteristics of patients between two groups
In our study we found an improvement in height, height standard deviation score (HSDS), and growth velocity (GV) values which could be assumed as the efficient growth response of the children to Samtropin
Summary
Recombinant human growth hormone (rhGH) has been established as an appropriate treatment to increase the growth rate in children with growth hormone deficiency (GHD), Turner syndrome (TS), Prader-Willi syndrome (PWS), chronic renal failure (CRF), and being born smallIt is shown that rhGH could improve the linear growth partly through stimulation of the production of insulin like growth factor-1 (IGF-1) [9]. Recombinant human growth hormone (rhGH) has been established as an appropriate treatment to increase the growth rate in children with growth hormone deficiency (GHD), Turner syndrome (TS), Prader-Willi syndrome (PWS), chronic renal failure (CRF), and being born small. The aim of the present study was to demonstrate the safety and efficacy of Samtropin in comparison with Norditropin; a product that is manufactured by NOVO Nordisk Company to treat the linear growth failure in pediatric GHD. 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
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