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In a prior randomized, placebo-controlled trial, investigators assessed whether denosumab prevents fractures in men undergoing androgen deprivation therapy (ADT) for nonmetastatic prostate cancer (N Engl J Med 2009; 361:745). Now, these investigators have conducted a prespecified substudy of patients in the trial to assess long-term changes in lean body mass (LBM) in response to ADT.
The analysis included 252 men (age ≥70, or <70 with history of osteoporotic fracture or baseline T-score <–1.0; more than 75% were overweight or obese) with biopsy-proven adenocarcinoma of the prostate and performance status 0 to 2; exclusion criteria included prostate-specific antigen (PSA) level ≥5 ng/mL after 1 month of ADT. Patients underwent total-body, dua…