Effect of Biosynthetic Growth Hormone and/or Ethinyl Estradiol on Adult Height in Patients With Turner Syndrome
Status:
Completed
Trial end date:
2003-09-01
Target enrollment:
Participant gender:
Summary
Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes.
Girls with Turner syndrome are very short as children and as adults. Although their growth
hormone secretion is almost always normal, giving injections of growth hormone to Turner
syndrome girls may increase their rate of growth. In addition, most girls with Turner
syndrome do not have normal ovaries.
In normal girls the ovaries begin producing small amounts of the female sex hormone, estrogen
at about 11 - 12 years of age. As girls grow older the level of estrogen increases. Estrogen
is responsible for the changes in girls known as feminization. During feminization the hips
grow wider, the breasts develop, there is an increase in the rate of growth, and eventually
girls experience their first menstrual period.
This study was designed to evaluate the effect of low dose estrogen, growth hormone, and the
combination of low dose estrogen and growth hormone on adult height in girls with Turner
syndrome. Patients will be entered into the study from ages 5 to 12 and will be randomly
placed into one of four groups.
1. Group one will receive low dose estrogen
2. Group two will receive growth hormone
3. Group three will receive both low dose estrogen and growth hormone
4. Group four will receive a placebo "sugar pill"
Once started, the treatment will continue until the patients approach their adult height, and
growth slows to less than 1/2 inch over the preceding year. This usually occurs by the age of
15 or 16.
Patients will be seen at the outpatient clinic every 6 months during the study and will
receive a routine check-up with blood and urine tests, and hand/wrist X-rays to determine
bone age. On patient's yearly visits they will have the density of bone measured in their
spine and forearm.
Phase:
Phase 2
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)