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  • Title: Growth hormone therapy with three dosage regimens in children with idiopathic short stature. European Study Group Participating Investigators.
    Author: Rekers-Mombarg LT, Massa GG, Wit JM, Matranga AM, Buckler JM, Butenandt O, Chaussain JL, Frisch H, Leiberman E, Yturriaga R, Aarskog D, Chatelain PG, Colle M, Dacou-Voutetakis C, Delemarre-van de Waal HA, Girard F, Gosen JJ, Irle U, Jansen M, Jean R, Job JC, Kaar ML, Kollemann F, Lenko HL, Waelkens JJ.
    Journal: J Pediatr; 1998 Mar; 132(3 Pt 1):455-60. PubMed ID: 9544901.
    Abstract:
    OBJECTIVE: In children with idiopathic short stature (ISS) we studied the growth-promoting effect at 4 years of recombinant human growth hormone (rhGH) therapy in three dose regimens and evaluated whether increasing the dosage after the first year could prevent a decline in height velocity (HV). DESIGN: Included were 223 patients who were treated with subcutaneous administrations of rhGH 6 days per week. They were randomized to three groups: 3 IU/m2 body surface/day, 4.5 IU/m2/day, and 3 IU/m2/day during the first year and 4.5 IU/m2/day thereafter, corresponding with dosages of 0.2 and 0.3 mg/kg body weight/week, respectively. Growth was compared with a standard of 229 untreated children with ISS [ISS standard]. RESULTS: During the first year of treatment HV almost doubled and was higher with 4.5 IU/m2 than with 3 IU/m2. In the second year HV no longer differed among the groups, but increasing the dosage slowed the rate of the fall of HV. During 4 years of therapy the height SD score for age increased by a mean (SD) of 2.5 (1.0) [ISS standards], or 1.2 (0.7) (British standards), bone age increased by 4.8 (1.3) years, and predicted adult height SD score increased by 1.5 (0.7). After 4 years the results of the group with 4.5 IU/m2 were slightly better than those of the other groups. When dropouts were included in the analysis (assuming a stable height SD score after discontinuation of rhGH therapy), height gain was still significant. CONCLUSIONS: During 4 years of rhGH therapy, growth and final height prognosis improved, slightly more with 4.5 IU/m2 than with 3 IU/m2 or 3 to 4.5 IU/m2. However, bone age advanced on average 4.8 years during this period; therefore, any effect on final height will probably be modest.
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