OBJECTIVE: To assess the effects of sustained aromatase inhibition in older hypogonadal men. DESIGN AND PATIENTS: In a 1-year randomized, double-blind, placebo-controlled trial, 88 men, aged 60 and older with testosterone levels between 5.2 and 10.4 nmol/L on a single measure or between 10.4 and 12.1 nmol/L on two consecutive measures, and symptoms of hypogonadism were recruited. Subjects received either anastrozole 1 mg daily or placebo. MEASUREMENTS: Changes in gonadal steroid hormone levels, body composition (by computerized tomography (CT) and dual x-ray absorptiometry (DXA)), strength, prostate specific antigen (PSA), symptoms of benign prostatic hypertrophy (BPH), hematocrit and lipid levels were assessed. RESULTS:Testosterone levels increased from 11.2 +/- 3.3 nmol/L at baseline to 18.2 +/- 4.8 nmol/L at month 3 (p < 0.0001 vs. placebo) while bioavailable testosterone levels increased from 2.7 +/- 0.8 nmol/L at baseline to 5.4 +/- 1.7 nmol/L at month 3 (p < 0.0001 vs. placebo). Testosterone and biotestosterone levels peaked at month 3 and then declined by month 12 (though they remained significantly higher than baseline and greater than placebo). Estradiol levels decreased from 55.8 +/- 15.4 pmol/L at baseline to 42.2 +/- 13.6 pmol/L at month 3 and then remained stable (p < 0.0001). Body composition and strength did not change, nor did PSA, BPH symptoms, hematocrit or lipid levels. CONCLUSIONS:Anastrozole administration normalized androgen production in older hypogonadal men and decreased estradiol production modestly. These alterations did not improve body composition or strength.
RCT Entities:
OBJECTIVE: To assess the effects of sustained aromatase inhibition in older hypogonadal men. DESIGN AND PATIENTS: In a 1-year randomized, double-blind, placebo-controlled trial, 88 men, aged 60 and older with testosterone levels between 5.2 and 10.4 nmol/L on a single measure or between 10.4 and 12.1 nmol/L on two consecutive measures, and symptoms of hypogonadism were recruited. Subjects received either anastrozole 1 mg daily or placebo. MEASUREMENTS: Changes in gonadal steroid hormone levels, body composition (by computerized tomography (CT) and dual x-ray absorptiometry (DXA)), strength, prostate specific antigen (PSA), symptoms of benign prostatic hypertrophy (BPH), hematocrit and lipid levels were assessed. RESULTS:Testosterone levels increased from 11.2 +/- 3.3 nmol/L at baseline to 18.2 +/- 4.8 nmol/L at month 3 (p < 0.0001 vs. placebo) while bioavailable testosterone levels increased from 2.7 +/- 0.8 nmol/L at baseline to 5.4 +/- 1.7 nmol/L at month 3 (p < 0.0001 vs. placebo). Testosterone and biotestosterone levels peaked at month 3 and then declined by month 12 (though they remained significantly higher than baseline and greater than placebo). Estradiol levels decreased from 55.8 +/- 15.4 pmol/L at baseline to 42.2 +/- 13.6 pmol/L at month 3 and then remained stable (p < 0.0001). Body composition and strength did not change, nor did PSA, BPH symptoms, hematocrit or lipid levels. CONCLUSIONS:Anastrozole administration normalized androgen production in older hypogonadal men and decreased estradiol production modestly. These alterations did not improve body composition or strength.
Authors: Sherri-Ann M Burnett-Bowie; Elizabeth A McKay; Hang Lee; Benjamin Z Leder Journal: J Clin Endocrinol Metab Date: 2009-10-09 Impact factor: 5.958