TerminatedPhase 4

TOM: Testosterone in Older Men With Sarcopenia

Stopped: Higher incidence of cardiovascular events in the testosterone arm of the trial. Decision taken by the DSMB on December 31st, 2009.

United States209 participantsStarted 2005-01

Plain-language 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.

Who can participate

Age range

65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in Physical Performance Measured by an Exercise Testing Regimen

Timeframe: baseline and 6 months

Trial details

NCT IDNCT00240981

SponsorBoston Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-12

Results submitted2017-02-08

View on ClinicalTrials.gov More Sarcopenia trials