Status:
COMPLETED
Testosterone and Growth Hormone for Bone Loss in Men
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Hypopituitarism
Hypogonadism
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 i...
Detailed Description
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 g...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00080483
Start Date
March 1 2004
End Date
September 1 2010
Last Update
June 13 2014
Active Locations (1)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104