TOM: Testosterone in Older Men With Sarcopenia

• Status: Terminated
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine whether testosterone replacement in older men with low testosterone levels will increase muscle strength, improve physical performance and overall sense of well being, and reduce fatigue.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Medical Center
• Collaborator: National Institute on Aging (NIA)
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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