Turner Syndrome Clinical Trial
Official title:
Humatrope Treatment to Final Height in Turner's Syndrome
A randomized, controlled trial in girls with Turner syndrome at least 7 years old and younger than 13 at study entry, to determine the efficacy and safety of Humatrope (somatropin) treatment in promoting linear growth to final height.
A randomized, controlled trial of Humatrope (somatropin) treatment in girls with Turner
syndrome at least 7 years old and younger than 13 at study entry.
Core study objectives are to determine the efficacy of Humatrope in promoting linear growth
to final height in girls with Turner syndrome, and to assess the safety of this treatment.
Core study completion criteria (protocol final height) are that the patient has both a
height velocity < 2 cm per year and a bone age of 14 years or greater.
Addendum 1 provides the option of Humatrope treatment to patients who were randomized to the
Control arm of the Core study and who discontinued from the study on or after December 19,
1997.
Addendum 2 objectives are: 1) to collect true final height data; 2) to evaluate hearing,
tympanic membrane function and other specific areas of interest with respect to the safety
of growth hormone therapy in Turner syndrome; 3) to evaluate pancreatic beta cell function
(glucose metabolism) in patients previously enrolled in the Core study.
Addendum 3 objective is to determine the parental origin of the retained X chromosome of an
appropriate subset of patients currently or previously enrolled in the Core study, and to
determine whether this parental origin holds any predictive value for spontaneous growth or
for response to growth hormone therapy.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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