At a glance
ClinicalIndex Comparison Record- ✓Documented hypothalamic or pituitary hormone deficiency
- ✓Testosterone deficiency: total serum testosterone <250 ng/dL on two 8 AM readings
- ✓Growth hormone deficiency: subnormal age-specific IGF-1 OR peak GH response to arginine-GHRH <4.1 ng/mL
- ✓Duration of testosterone and growth hormone deficiencies of 2 or more years
- ✕Current or prior testosterone treatment within 2 years of study entry
- ✕Current or prior growth hormone treatment within 3 years of study entry
- ✕Use of androgens (androstenedione, DHEA), estrogens, or antiandrogens (spironolactone, ketoconazole)
- ✕Diseases affecting bone metabolism (e.g., hyperparathyroidism)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Will Testosterone and Growth Hormone Improve Bone Structure?
In Brief
A Phase 2 clinical trial evaluating Testosterone plus somatropin and testosterone for Hypopituitarism and 2 related conditions. Completed, enrolled 35 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
AndoGel 5 grams transdermally a day for two years Somatropin 2 µg/kg body weight/day for two years
AndroGel transdermally 5 g a day for two years