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Growth hormone therapy found safe and effective for children with ISS
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Compared with untreated controls, growth hormone treatment increased final height in non–GH-deficient children with idiopathic short stature.
Researchers from the Karolinska Institute and other sites in Sweden also found that GH treatment increased final height for children in this patient population who were born small for gestational age.
In a randomized, controlled trial, the researchers enrolled 177 patients with idiopathic short stature. Among those children who remained prepubertal, 47 were randomly assigned to a control group; 49 were assigned to 33 mcg/kg per day somatropin (Genotropin, Pfizer); and 50 were assigned to 67 mcg/kg per day somatropin. Thirty-one children who had already entered puberty were randomly assigned to 67 mcg/kg per day somatropin (n=16) or to the control group (n=15).
At six years follow-up, the researchers found that children treated with GH therapy had a mean gain of 1.3 standard deviation score, or 8 cm. The final height SD score in children in the treatment population was –1.5 vs. –2.4 in the control group (P<.001). Broken down by dose, the final height SD score for the 33 mcg/kg per day group was –1.7 and for the 67 mcg/kg per day group was –1.4 (P<.032).
The difference in SD score to midparental height was –0.2 in the GH group vs. –1.0 in the control group (P<.001). Gain in height SD score was 1.3 in the GH–treated group and 0.2 for controls (P<.001).
After one year, the researchers identified a dose-dependent relationship for all outcome variables. “GH therapy was safe and had no impact on time to onset of puberty,” they wrote.
J Endocrinol Metab. 2008;93:4342-4350.