Testosterone supplementation did not prevent cognitive decline or increase bone mineral density in older men

Randomized placebo-controlled trial.

{Concealed}†.*

Blinded (participants, clinicians).*

6 months.

University Medical Center in Utrecht, the Netherlands.

237 men 60 to 80 years of age (mean age 67 y) who had testosterone levels < 13.7 nmol/L (394.8 ng/dL). Exclusion criteria included myocardial infarction or cerebrovascular accident in the past 6 months; heart failure unless medically treated and not symptomatic; cancer in the past 5 years except nonmelanoma skin cancer and hormone-dependent tumor; renal or liver disease; hematologic abnormalities; epilepsy or use of antiepileptic medication; > 1 migraine per month; diabetes mellitus; fasting glucose level ≥ 6.9 mmol/L (124 mg/dL); corticosteroid use (≥ 7.5 mg/d in the past 6 mo except for prednisolone use for ≤ 7 d, or inhalation of ≥ 800 µg/d during past 6 mo); use of testosterone esters and similar substances in the past 60 days; prostate hyperplasia; or elevated prostate-specific antigen level (age 60 to 69 y ≥ 4.5 µg/L; age ≥ 70 y ≥ 6.5 µg/L).

Testosterone undecenoate, 160 mg/d (2 capsules of 40 mg twice daily) (n = 120), or placebo (n = 117).

Cognitive function, assessed using the Dutch version of the Rey Auditory-Verbal Learning Test (RAVLT). Participants were asked to recall 15 words 5 consecutive times immediately (maximum score 75) and after 15 minutes (maximum score 15). Secondary outcomes included bone mineral density (BMD) and the metabolic syndrome. The study had 80% power to detect an 18% improvement in the RAVLT (equivalent to an improvement of 6 words, α = 0.05).

87% completed the study. 94% were included in the modified intention-to-treat analysis (men with ≥ 2 measurements).

At 6 months, groups did not differ for change in the RAVLT or BMD or for the metabolic syndrome (Table).

In older men with low testosterone levels, testosterone supplementation did not improve cognitive function or bone mineral density at 6 months.