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THREE YEAR EFFICACY RESULTS OF A PLACEBO-CONTROLLED TO DOSE RESPONSE STUDY OF HUMAN GROWTH HORMONE IN TURNER'S SYNDROME

Two hundred thirty-two females with Turner's syndrome, diagnosed by karyotype, were enrolled in this ongoing, age-stratified, double-blinded, randomized, parallel, placebo-controlled (18 months) to dose response study conducted by 50 investigational sites in the United States. Patients were randomized to one of five treatment groups: 0.09 mg/kg thrice weekly with or without daily estrogen, 0.12 mg/kg thrice weekly with or without daily estrogen, or placebo injections with placebo tablets. After 18 months, significant differences (by rank based analysis) were observed between the least responsive treatment group and the remaining four treatment groups for mean change in height, Lyon height standard deviation score (SDS) and growth rate. Additionally, the least responsive treatment group demonstrated a significant (p<0.01) increase in 18-month mean Lyon SDS over baseline (+0.14, n=41). Following this initial 18-month period, the least responsive treatment group was reassigned to one of the remaining treatment groups to become a dose response study extended to final height. After 36 months on study, the initial least responsive treatment group (during the first 18 months) remained statistically different from the other treatment groups for mean change in height for the first 36 months. We therefore believe that somatropin with or without estrogen causes a significant increase in growth rate, height, and change in height after 36 months, however the overall effect on final height remains to be quantified. The increase in mean Lyon SDS during the initial 18 months seen for the least responsive treatment group suggests that using Lyon's data as a historical control may over estimate the ultimate effect of growth hormone on final height for U.S. Turner syndrome patients.