Testosterone and Growth Hormone for Bone Loss in Men
Condition: Hypopituitarism; Hypogonadism; Growth Hormone Deficiency
MeSH terms: Hypopituitarism; Hypogonadism
Intervention: Testosterone plus somatropin; testosterone
Intervention description: 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
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented hypothalamic or pituitary hormone deficiency

          -  Testosterone deficiency, defined as total serum testosterone less than 250 ng/dL at
             two 8 AM readings

          -  Growth hormone deficiency, defined by either of the following:

          -  For subjects who have thyroxine and cortisol deficiencies, either a subnormal
             age-specific IGF-1 or a peak GH response to arginine-GHRH of less than 4.1 ng/mL

          -  For subjects who do not have thyroxine and cortisol deficiencies, either a subnormal
             age-specific IGF-1 or a peak GH response to arginine-GHRH of less than 4.1 ng/mL

          -  Duration of testosterone and growth hormone deficiencies of two years or more

          -  Replacement of cortisol and/or thyroxine deficiencies

          -  Able to give informed consent

        Exclusion Criteria:

          -  Current testosterone treatment or treatment during the two years prior to study entry

          -  Current growth hormone treatment or treatment during the three years prior to study
             entry

          -  Use of other prescription or over-the-counter androgens (androstenedione, DHEA),
             estrogens, or antiandrogens (spironolactone, ketoconazole)

          -  Diseases that could influence bone, such as hyperparathyroidism

          -  Medications that could influence bone, such as anticonvulsants or glucocorticoids
             (prednisone greater than 20 mg/day for longer than 2 weeks/year). Calcium and
             over-the-counter vitamin D supplements are allowed.

          -  Cancer that could limit life expectancy to fewer than 5 years

          -  Neuromuscular disease or history of stroke with residual neurological defect

          -  Severe or uncontrolled psychiatric illness or dementia

          -  Noncancerous enlargement of the prostate gland (American Urological Association
             symptom score greater than 21)

          -  Prostate cancer by history, prostate nodule on digital rectal exam (DRE), or prostate
             specific antigen (PSA) greater than 4

          -  Current alcohol or drug dependence

          -  Heart failure (New York class III or IV)

          -  Unstable angina

          -  Myocardial infarction within 3 months of study entry

          -  Liver disease (ALT greater than 3 x normal)

          -  Renal disease (serum creatinine greater than 2.5 mg/dl)

          -  Diabetes mellitus (glycosolated hemoglobin greater than 8.0%)

          -  Hypertension (systolic BP greater than 160 or diastolic BP greater than 100 mm Hg)

          -  Hematocrit greater than 48%

          -  Weight greater than 300 pounds

          -  Poor quality scan at baseline even when repeated

          -  Untreated, severe, obstructive sleep apnea (Epworth sleepiness score greater than 10)

          -  Unable to undergo an MRI because of a cardiac pacemaker or ferrometallic objects in
             the body