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Clinical trial with somatonorm in idiopathic growth hormone deficiency in children
Insights
Somatonorm treatment significantly improved growth velocity in children with idiopathic growth hormone deficiency. While effective, monitoring thyroid hormone levels and antibody formation is recommended.
Area of Science:
- Pediatrics
- Endocrinology
- Pharmacology
Background:
- Idiopathic growth hormone (GH) deficiency is a condition affecting childhood growth.
- Effective treatment options are crucial for improving growth outcomes in affected children.
Purpose of the Study:
- To evaluate the efficacy and safety of Somatonorm in treating idiopathic GH deficiency in pediatric patients in China.
- To compare different Somatonorm administration routes and dosages.
Main Methods:
- A study involving 9 children diagnosed with idiopathic GH deficiency.
- Treatment with Somatonorm administered over a 1-year period.
- Assessment of growth velocity, human growth hormone (hGH) levels, bone age, Somatomedin-C (SMC) levels, blood sugar, and alkaline phosphatase.
Main Results:
- Growth velocity increased significantly from 2.6 cm/year to 10.7 cm/year after 1 year of treatment.
- Subcutaneous injection of 0.1 IU/kg resulted in a larger hGH response than intramuscular injection of 0.17 IU/kg.
- No significant bone age advancement was observed; no correlation between height velocity and SMC levels.
- Increased blood sugar and alkaline phosphatase levels were noted, with no significant side effects reported.
- Two patients developed anti-hGH antibodies without compromising growth velocity; three patients showed decreased T4 levels.
Conclusions:
- Somatonorm is an effective treatment for idiopathic GH deficiency in children, leading to substantial growth improvement.
- Optimal Somatonorm dosage and administration route require further investigation.
- While generally safe, potential impacts on thyroid function and antibody development warrant monitoring during therapy.
Abstract:
This article reports the efficacy and safety of treatment with Somatonorm in 9 children with idiopathic growth hormone (GH) deficiency in China. The growth velocity increased from 2.6 +/- 0.2 cm/year before treatment to 10.7 +/- 0.5 cm/year at the end of 1-year treatment. The increment of human growth hormone (hGH) level and area under the response curve above the baseline level were larger after one injection of Somatonorm at the dose of 0.1 IU/kg sc than that of 0.17 IU/kg im. Increments of delayed bone age were not significant. There was no correlation between the increase of height growth velocities and the serum Somatomedin-C (SMC) levels during hGH therapy (r = -0.055). Blood sugar levels and blood alkaline phosphatase concentrations increased significantly after therapy. There were no significant side effects. Serum T4 levels of 3 patients dropped below normal after treatment. Serum anti-hGH antibody appeared at 3-12 month in 2 patients, but it did not attenuate the growth velocity.