Spanish multicenter clinical trial of recombinant growth hormone produced in mammalian cells for treatment of growth failure due to idiopathic growth hormone deficiency. Spanish Multicenter Study Group.
A total of 17 patients (14 boys, 3 girls) with poor growth due to idiopathic growth hormone deficiency (IGHD) were treated for 12 months with recombinant human growth hormone (rhGH; Saizen), 0.5 IU/kg body weight per week administered by subcutaneous injection on a daily basis. Therapy significantly increased growth velocity (GV) from 4.0 +/- 1.5 to 10.1 +/- 2.4 cm/year (p < 0.001). Correspondingly, GV standard deviation score (GV SDS) for chronological age (CA) increased from -2.7 +/- 1.6 to +4.5 +/- 2.8; GV SDS for bone age (BA) increased from -4.0 +/- 2.0 to +3.6 +/- 3.3; and patient height SDS-CA increased from -3.5 +/- 1.1 to -2.4 +/- 0.7. Changes in these parameters were significant at p < 0.001. During the course of the study, mean plasma IGF-1 levels rose significantly from 0.3 +/- 0.2 IU/ml to 1.3 +/- 1.2 IU/ml (p < 0.01). BA maturation proceeded at approximately 1 year per treatment year. Therapy was well tolerated. Anti-hGH antibodies were seen in only 1 patient at a low concentration, and did not appear to affect GV. This study demonstrates that rhGH is safe and efficacious when used to increase height in patients with IGHD.
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Unidad de Endocrinologia Pediatrica Hospital Infantil San Joan de Deu, Barcelona, Spain.
D000375:Aging / Q000502:physiology; D000818:Animals; D001846:Bone Development / Q000187:drug effects; D002460:Cell Line / Q000378:metabolism; D002648:Child; D005260:Female; D006130:Growth Disorders / Q000188:drug therapy / Q000209:etiology*; D013006:Growth Hormone / Q000096:biosynthesis / Q000172:deficiency* / Q000627:therapeutic use; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000032:analysis; D008297:Male; D011994:Recombinant Proteins
D011994:Recombinant Proteins; D007334:Insulin-Like Growth Factor I; D013006:Growth Hormone