Hypogonadism Clinical Trial
Official title:
Will Testosterone and Growth Hormone Improve Bone Structure?
Deficiency of testosterone, growth hormone, or both hormones can result in osteoporosis. If either hormone is replaced, the condition of the bones improves. The purpose of this study is to determine if dual hormone treatment for men deficient in testosterone and growth hormone improves bone structure more than testosterone treatment alone.
Replacement of testosterone or growth hormone in patients who are deficient improves
osteoporosis associated with these deficiencies. In some tissues, such as muscle, the
effects of testosterone and growth hormone are additive, but it is not known if the effects
are additive in bone as well. This study will compare the effects of testosterone alone with
testosterone plus growth hormone in improving bone structure in men with total pituitary
hormone deficiency.
Participants in this study will be men who have pituitary or hypothalamic disease and have
deficiencies of all pituitary hormones, but who have not been treated with either
testosterone or growth hormone. The men will be randomly assigned to receive either
testosterone alone or testosterone plus growth hormone for two years. Testosterone in a gel
form will be applied daily to the skin. Growth hormone will be self-administered by daily
subcutaneous injection. Blood concentrations of both hormones will be monitored with blood
tests every 3 months during the 2-year study. Doses of the hormones will be adjusted to keep
blood concentrations of the hormones within the normal range. Changes in bone structure will
be assessed noninvasively before treatment and after one year and two years of treatment by
magnetic resonance microimaging (µMRI) and dual energy X-ray absorptiometry (DEXA).
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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