Effects of Aromatase Inhibition Versus Testosterone in Older Men With Low Testosterone: Randomized-Controlled Trial.
Condition: Hypogonadism; Diabetes; Sarcopenia; Osteoporosis; Depression
MeSH terms: Osteoporosis; Sarcopenia; Hypogonadism
Intervention: Androgel (Testosterone Gel); Anastrozole (Aromatase Inhibitor); Placebo tablet; Placebo gel; Calcium Cardone 500mg with vitamin D 400 IU
Intervention description: 1 mg tablet for 12 months; Daily for 12 months; Daily for 12 months; 1 tablet three times a day
Intervention MeSH terms: Vitamin D; Anastrozole; Calcium; Testosterone; Aromatase Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: Male
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Estrogen; Glucose Tolerance; Bone Density; Quality-of-Life; Sarcopenia

Summary:

      Background: Men≥65 years often produce lower levels of testosterone, meaning there is less
      testosterone circulating to the tissues of the body. This is associated with negative effects
      on muscle strength, bone density, sexual function, mood, and the ability to think to the best
      of one's ability. Testosterone replacement therapy often involves injections, patches, or
      gels that help to raise circulating testosterone levels, but these therapies often have side
      effects because they lead to imbalance of other hormones. Researchers have been studying the
      effectiveness of anastrozole, a drug that can lower estrogen levels while simultaneously
      increasing testosterone levels, as a treatment for the negative effects of decreased
      circulating testosterone levels that occur naturally with aging. Objectives: To evaluate
      whether anastrozole is as effective as testosterone gel in improving bone and muscle
      strength, hormone levels, and brain function in men over 65 years of age. Eligibility:
      Healthy men at least 65 years of age who have low levels of testosterone. Design: The study
      involves six study visits over a total of 12 months: screening, baseline, 6 weeks, 3 months,
      6 months, and 12 months. All participants will receive calcium and vitamin D supplements to
      take daily, and will be randomized to one of three groups:Testosterone gel and placebo
      tablet, Anastrozole tablet and placebo gel, Placebo tablet and gel. Participants will have
      the following tests at each specified visit:Screening: Blood tests and rectal ultrasound to
      evaluate the prostate;Baseline: Blood and urine tests; growth hormone levels, muscle
      strength, bone density, and balance evaluation; imaging studies; cognitive testing; and
      questionnaires on quality of life, sexual function, depression, and urinary symptoms;Six
      weeks: Blood tests and dose adjustment of the gel or tablet;Three months: Blood and urine
      tests; growth hormone, muscle strength, bone density, and balance evaluation; and
      questionnaires on quality of life, sexual function, depression, and urinary symptoms;Six
      months: Blood and urine tests; muscle strength, bone density, and balance evaluation;
      cognitive testing; and questionnaires on quality of life, sexual function, depression, and
      urinary symptoms;Twelve months: Blood and urine tests; rectal ultrasound; muscle strength,
      bone density, and balance evaluation; imaging studies; cognitive testing; and questionnaires
      on quality of life, sexual function, depression, and urinary symptoms.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

               1. Men age 65 years or older

               2. Serum testosterone level less than or equal to 350 ng/dl

               3. Subject is able to complete an informed consent

        EXCLUSION CRITERIA:

          1. History of Stroke

          2. History of Dementia

          3. History of Diabetes

          4. Blood pressure at rest of > 155/90 mmHg. Elevated systolic or diastolic reading
             renders subject ineligible

          5. Chronic medical condition, i.e. congestive heart failure

          6. Arthritis, severe enough to prevent completion of the strength testing, history of
             joint replacement of knees or hip.

          7. Inability to walk 50 meters

          8. Known disease of the bone and/or taking medications to treat osteoporosis, i.e.

             Fosamax, Evista, Miacalcin

          9. History of Gastric surgery

         10. History of prostate cancer or any other cancers, including blood dyscrasias

         11. History of severe benign prostatic hyperplasia (causing urinary problems)

         12. History of heart attack or open-heart surgery within the past 6 months

         13. Use of steroids within the past 3 months, including prednisone and/or cortisone
             injections, and inhaled steroids. Topical steroid cream is acceptable.

         14. If you do not agree to refrain from taking the drugs Viagra, Cialis or Levitra for the
             duration of the study

         15. 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

         16. Use of anti-androgen medications, i.e. Aldactone, Tagamet, Proscar, estrogens

         17. Use of Dilantin or Phenobarbital

         18. Alcohol intake > 30 grams (drink more than 2 beers per day OR more than 1 glass of
             wine or cocktail daily)

         19. Currently smokes any tobacco product

         20. Having started a new medication during the past three months which may interfere with
             the outcome measures of the study

         21. Polycythemia

         22. Prostate specific antigen > 4.0 ng/dl

         23. Hematocrit < 36

         24. Liver function tests greater than 2 times upper normal limits or abnormal
             electrolytes, calcium or Parathyroid hormone , at the discretion of the investigator

         25. Mini Mental Status Exam score less than or equal to 24