Norditropin, a recombinant growth hormone in the treatment of children with somatotropic insufficiency

The efficacy and safety of recombinant growth hormone (GH) Norditropin (Novo Nordisk) for children suffering from somatotropic insufficiency have been assessed in clinical trials. Twenty-three children (8 girls and 15 boys) aged 6.3 to 17.5 (mean ± SD: 12.3 ± 5.96 years) were followed up. The diagnosis was verified by clofelin and/or insulin stimulation tests (max. serum level of GH in the tests no more than 7 ng/ml) and by measuring GH concentration in the nocturnal portion of urine by U-hGH NordiTest TM (Novo Nordisk) kits. Norditropin was injected daily subcutaneously in the evening in a daily dose of 0.07 to 0.1 IU/kg b. w. The treatment was administered for 6 months. During the first 3 months of treatment growth SDS in relation to chronological age increased from -4.5 ± 1.12 to -3.9 ± 1.08 (p<0.0001) and the velocity of growth increased from 2.8 ± 1.05 to 18.1 ± 4.73 cm/year (p<0.0001). A further increment in body length was observed during the second trimester, although the change of growth SDS in relation to chronological age was less expressed than during the first trimester (0.5 ± 0.19 vs. 0.35 ± 0.19, p=0.012). The gain in height over 6 months of treatment was 7.6 ± 1.01 cm (min. 6.2 cm, max. 9.8 cm), Bone age altered from 6.3 ± 2.99 to 7.3 + 2.66 years (p=0.005) during 6  months; at the same time, despite acceleration of bone age, therapy was conducive to growth SDS increase in relation to bone age (from 1.1 ± 2.87 to 1.7 ± 2.0; Z=2.1, p=0.04), this indicating a better growth prognosis. The treatment caused virtually no side effects of any type. Hence, clinical trials demonstrated the efficacy and safety of GH Norditropin for children with somatotropic insufficiency.

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