Effects of Aromatase Inhibition Versus Testosterone in Older Men With Low Testosterone: Randomized-Controlled Trial.

Approximately 20% of men over the age of 70 have low testosterone levels. In some studies, testosterone replacement has resulted in improvement in bone mass, muscle strength, quality of life and memory function. In the body, testosterone is converted into estrogen. Hence, it is unclear whether these beneficial effects are due to testosterone or estrogen. Research has shown that inhibition of estrogen production in men results in an increase in testosterone levels.

In this study, patients will be assigned to one of three groups: one group will receive testosterone gel and a placebo tablet, one group will receive a 1mg Anastrozole tablet and a placebo gel, and one group will receive a placebo tablet and placebo gel. Each group will receive a daily dose of calcium with vitamin D. The study requires 6 visits over a 12-month period for testing and evaluation. Two of the 6 visits will require an overnight stay in the hospital so that an intravenous (IV) line can be placed in the arm to allow samples to be drawn throughout the night. Testing will include a cardiac stress test, a glucose tolerance test, bone and muscle tests, evaluation of memory function, etc. For the safety of the prostate, we will perform a prostate ultrasound at the start and end of the study and we will monitor urinary symptoms, prostate specific antigen (PSA) levels and the prostate exam throughout the study.

• INCLUSION CRITERIA:

• Men age 65 years or older
• Serum testosterone level less than or equal to 350 ng/dl
• Subject is able to complete an informed consent

Exclusion criteria

• History of Stroke
• History of Dementia
• History of Diabetes
• Blood pressure at rest of > 155/90 mmHg. Elevated systolic or diastolic reading renders subject ineligible
• Chronic medical condition, i.e. congestive heart failure
• Arthritis, severe enough to prevent completion of the strength testing, history of joint replacement of knees or hip.
• Inability to walk 50 meters
• Known disease of the bone and/or taking medications to treat osteoporosis, i.e.

Fosamax, Evista, Miacalcin

• History of Gastric surgery
• History of prostate cancer or any other cancers, including blood dyscrasias
• History of severe benign prostatic hyperplasia (causing urinary problems)
• History of heart attack or open-heart surgery within the past 6 months
• Use of steroids within the past 3 months, including prednisone and/or cortisone injections, and inhaled steroids. Topical steroid cream is acceptable.
• If you do not agree to refrain from taking the drugs Viagra, Cialis or Levitra for the duration of the study
• Use of anabolic steroids, i.e. testosterone, (or any analog of testosterone) Dehydroepiandrosterone or any growth promoters i.e. growth hormone itself or analogs of growth hormone
• Use of anti-androgen medications, i.e. Aldactone, Tagamet, Proscar, estrogens
• Use of Dilantin or Phenobarbital
• Alcohol intake > 30 grams (drink more than 2 beers per day OR more than 1 glass of wine or cocktail daily)
• Currently smokes any tobacco product
• Having started a new medication during the past three months which may interfere with the outcome measures of the study
• Polycythemia
• Prostate specific antigen > 4.0 ng/dl
• Hematocrit < 36
• Liver function tests greater than 2 times upper normal limits or abnormal electrolytes, calcium or Parathyroid hormone , at the discretion of the investigator
• Mini Mental Status Exam score less than or equal to 24