TOM: Testosterone in Older Men With Sarcopenia

Boston Medical Center (BMC)

Status and phase

Terminated

Phase 4

Conditions

Muscular Diseases

Hypogonadism

Sarcopenia

Treatments

Drug: Topical testosterone gel 1% (active formulation)

Drug: Topical gel (placebo formulation)

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00240981

U01AG014369 (U.S. NIH Grant/Contract)

AG0057

Details and patient eligibility

About

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.

Full description

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.

Enrollment

209 patients

Sex

Male

Ages

65+ years old

Volunteers

No Healthy Volunteers

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