TOM: Testosterone in Older Men With Sarcopenia

The primary objective of this study is to determine whether testosterone replacement in
older men, who have low testosterone levels and mild to moderate physical impairment, will
increase their maximal voluntary muscle strength of major upper and lower extremity muscle
groups. The second objective is to determine whether testosterone replacement will improve
the power of knee extension, physical performance tests, the level of physical activity
(measured by 3D accelerometer), self-reported disability, exercise tolerance and mobility.
The third objective is to determine whether testosterone supplementation improves fatigue,
affect, and overall sense of well being in older men with low testosterone levels. A fourth
objective is to define the Minimum Clinically Important Differences in physical measures
perceived by the participants (MCID).

Participant involvement will require 15-17 clinic visits over 28 weeks. Five to 7 of these
visits are for physical testing, including body composition, muscle performance, and
physical function. Throughout the study, hormone measurements will be obtained.

Inclusion Criteria:

- Community dwelling, ages 65 and older

- Self-reported difficulty in climbing 10 steps without resting, or difficulty in
walking 2 or 3 blocks outside on level ground

- A score of 4 to 9 on the Short Physical Performance Battery (mild to moderate
physical impairment)

- Total serum testosterone level (TT) < 350 ng/dL and > 100 ng/dL

- Without dementia (Mini-Mental State Examination [MMSE] score > 24)

Exclusion Criteria:

- Use of testosterone, anabolic steroids, dehydroepiandrosterone (DHEA),
androstenedione or recombinant growth hormone (rGH) in the past year

- Alcohol or drug abuse

- Use of anti-convulsants or glucocorticoids (equivalent to prednisone > 20 mg/day)

- Prostate cancer, breast cancer or other cancers with life expectancy < 5 years

- Limiting neuromuscular, joint or bone disease, or history of stroke with residual
neurological problems

- Any neurological condition that would impact cognitive functioning including:

- epilepsy

- multiple sclerosis

- HIV

- Parkinson's disease

- stroke

- other focal lesion

- Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I
psychiatric disorder in past year or use of psychotropic medications in 6 months

- Abnormal prostate examination; PSA > 4 ng/mL; or BPH symptom score > 21

- Unstable angina, New York (NY) class III or IV congestive heart failure or myocardial
infarction within 3 months of entry

- Abnormal laboratory values (at discretion of principal investigator)

- Untreated thyroid disease; systolic blood pressure > 160 or diastolic > 100 mm Hg

- Body mass index > 40 kg/m2

- Untreated severe obstructive sleep apnea