Results from the first 2 years of a clinical trial with recombinant DNA-derived human growth hormone (somatrem) in Turner's syndrome.

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.

RCT Entities:   Population Interventions Outcomes