4553 Background: In men with prostate cancer, androgen deprivation therapy by either surgical orchiectomy or treatment with a gonadotropin releasing hormone agonist decreases bone mineral density (BMD) and increases clinical fracture risk. In postmenopausal women, selective estrogen receptor modulators (SERMs) increase BMD and decrease fracture incidence. We conducted a multicenter randomized controlled trial to evaluate the efficacy of the SERM toremifene citrate in men with prostate cancer. Methods: In a 24-month prospective study, 1392 men with prostate cancer who have been treated with ADT for at least 6 months and are at increased risk of fracture based on either being older than 70 years of age or having evidence of osteopenia by baseline dual energy X-ray absorptiometry (DEXA) scan were assigned randomly (1:1) to receive either toremifene citrate 80mg or placebo (by mouth daily). The primary study endpoint is proportion of men with one or more fracture at 24 months. Secondary endpoints include changes in BMD of the hip and spine. Here we report the results of a planned interim analysis of 12-month changes in BMD for the first 200 subjects. Results: As summarized in the table below, toremifene citrate significantly increased BMD of the lumbar spine, total hip, and femoral neck compared to placebo. Conclusions: In men receiving ADT for prostate cancer, toremifene citrate significantly increased BMD of the hip and spine. In randomized controlled trials of SERMs in postmenopausal women, similar BMD improvements translated into statistically and clinically significant decreases in fractures risk. These interim results of BMD effects suggest toremifene citrate has the potential to provide a fracture reduction benefit in men with prostate cancer, the hypothesis being tested in the ongoing study. [Table: see text] [Table: see text]
Comparative effectiveness of different exercise on bone mineral density in postmenopausal women: a systematic review and network meta-analysis of randomized controlled trials
