Clinical trial: Testosterone and Growth Hormone for Bone Loss in Men (NCT00080483)

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
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 19-year-old male came to clinic with some sexual concern.  He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates.  On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH.

Patient description (patient's own words): I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels.

Does the patient match the trial criteria? Contradiction