A total of 70 subjects with
Turner's syndrome from 11 centres were enrolled in a study of
somatrem. After an initial observation period, they were randomly assigned to one of four groups, receiving no treatment (Group 1, control);
oxandrolone, 0.125 mg/kg/day (Group 2);
somatrem, 0.125 mg/kg 3 times/week (Group 3); or a combination of
somatrem and
oxandrolone on the above dose regimens (Group 4). After 12-20 months, Groups 1 (control), 2 (
oxandrolone) and 4 (combination) were treated with
somatrem, 0.125 mg/kg 3 times/week, and
oxandrolone, 0.0625 mg/kg/day; Group 3 remained on
somatrem, 0.125 mg/kg 3 times/week. All three treatment groups showed a statistically significant increase during year 1 in growth velocity over both their pretreatment growth rates and the control group growth rate. These increases were slightly less in year 2 for the
somatrem and combination
therapy groups, but remained significantly higher than the year 1 control group growth rate. Plasma
IGF-1 levels were elevated in years 1 and 2 in the
somatrem and combination groups. Adverse events were few with the
somatrem group, though mild
virilization occurred with
oxandrolone, alone or in combination. Bone age advancement was observed with all treatments but was greater with combination
therapy; it was accompanied by height age advancement. The effect of this
therapy on predicted adult height was also evaluated.