OUTCOME OF A 4-YEAR RANDOMIZED STUDY OF DAILY VERSUS 3 TIMES WEEKLY SOMATROPIN TREATMENT IN PREPUBERTAL NAIVE GROWTH HORMONE-DEFICIENT CHILDREN

A comparison was made of the growth responses of prepubertal naive GH- deficient children who were randomly assigned to receive 0.3 mg/kg . w eek recombinant human GH administered either daily (QD) or three times weekly (TIW) over 4 yr. The effects of the two regimens on annual gro wth velocity, change in height SD score, bone maturation, and age at o nset of puberty are presented as the mean +/- SD. During each of the 4 yr, the annual growth velocity was significantly greater in the QD vs . TIW group. At 48 months, the mean total gain in height was 9.7 cm gr eater in the QD group (38.4 +/- 5.5) than that in the TIW group (28.7 +/- 3.2; P = 0.0002). The mean height SD score at the end of each year was significantly greater in the QD group. After 4 yr, the total gain in height Sn score was 3.2 +/- 1.2 in the QD group compared to 1.5 +/ - 0.5 in the TIW group (P = 0.0003). The SD score at 4 yr was 0.2 in t he QD group (pretreatment, -2.9) compared to -1.4 in the TIW group (pr etreatment, -2.9). After 4 yr of rhGH treatment, the increment in bone age was similar in the QD (4.9 +/- 1.0 yr) and TIW (4.8 +/- 1.1 yr) g roups. The change in height age minus the change in bone age was more favorable in the QD (1.2 +/- 0.8 yr) than in the TIW (0.0 +/- 0.9 yr) group (P = 0.003). The mean age at onset of puberty in boys was the sa me in the QD (13.2 yr) and TIW (13.0 yr) groups (P = 0.71), and the me an bone age at the start of puberty was also similar (11.5 in QD and 1 1.3 in TIW groups; P = 0.66). The advantages of QD rhGH treatment in p repubertal GH-deficient children after 4 yr were additional gains of 1 .7 height SD score and 9.7 cm in height over those treated with the TI W regimen (P = 0.0002).