Michael J. Lichtenstein, MD, MSc
In older men with mobility limitations, is testosterone treatment effective and safe?
Randomized placebo-controlled trial (Testosterone in Older Men with Mobility Limitations [TOM] trial). ClinicalTrials.gov NCT00240981.
Unclear allocation concealment.*
Blinded (patients and study personnel).*
≤ 24 weeks.
3 health care centers in Massachusetts, USA.
209 men ≥ 65 years of age (mean age 74 y) who had a total serum testosterone level 3.5 to 12.1 nmol/L (100 to 350 mg/dL) or a free serum testosterone level of < 173 pmol/L (50 pg/mL) in a morning blood sample, and mobility limitations. Exclusion criteria included uncontrolled hypertension, unstable angina, myocardial infarction within 3 months, New York Heart Association class III or IV congestive heart failure, active cancer, severe lower urinary tract symptoms, untreated severe obstructive sleep apnea, glucocorticoid or anabolic steroid therapy, glycated hemoglobin level > 8.5%, hematocrit > 48%, prostate-specific antigen level > 4 µg/L (4 ng/mL), and body mass index > 40.
Testosterone (n = 106) or placebo (n = 103) in 10 g of transdermal gel applied once daily for 6 months. Initial testosterone dose was 100 mg; 2 weeks after randomization, the dose was adjusted to 15 g/d if the average of 2 testosterone measurements was < 17.4 nmol/L (500 ng/dL), or to 5 g/d if the average of 2 testosterone measurements was > 34.7 nmol/L (1000 ng/dL).
Primary efficacy outcome was maximum voluntary muscle strength in a leg-press exercise. Safety outcomes included adverse events.
100% in safety analysis.
The trial was discontinued early because of increased cardiovascular (CV) events in the testosterone group; results for the primary efficacy outcome are not reported here as < 80% of patients were included in the analysis. The main safety results are in the Table.
In older men with mobility limitations, testosterone increased risk for adverse events.
Testosterone vs placebo in older men with mobility limitations†
†Abbreviations defined in Glossary. RRI, NNH, and CI calculated from data in article.
‡Includes MedDRA-classified cardiac events plus stenting and bypass procedures; peripheral edema; elevated blood pressure, arrhythmias, and electrocardiographic changes; and stroke and syncope.
§Adjusted for multiple potentially confounding variables.
||Cough, asthma exacerbation, shortness of breath, sinus problems, exacerbation of chronic obstructive pulmonary disease, and sleep apnea.
¶Skin reactions at gel application site, itching, erythema, psoriasis, foot ulcers, and increased hair growth.
Lichtenstein MJ. Testosterone increased risk for adverse events in older men with mobility limitations. Ann Intern Med. 2010;153:JC6–7. doi: 10.7326/0003-4819-153-12-201012210-02007
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Published: Ann Intern Med. 2010;153(12):JC6-7.
Geriatric Medicine, Prevention/Screening.
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