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Toremifene improves bone mineral density in men treated with androgen deprivation therapy for prostate cancer, data show

Tuesday, January 01 2008 | Comments

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What's This? Treatment with toremifene appears to increase bone mineral density in men who are being treated with androgen deprivation therapy (ADT) for prostate cancer, according to interim data from an ongoing study.

"Osteoporosis has emerged as a clinically important adverse effect of ADT," the authors of the study wrote. "Clinical fractures during ADT correlate with shorter overall survival."

To examine the effects of toremifene on BMD, which is a surrogate for fracture risk, researchers conducted a planned interim analysis of data from the first 197 individuals to complete 1 year of follow-up in an ongoing trial of toremifene. In the Phase III trial, 1,392 men aged >=50 years with prostate cancer who were receiving ADT were randomized to receive toremifene 80 mg/day or placebo. BMD of the lumbar spine, total hip, and femoral neck, which is a secondary outcome in the study, served as the primary outcome measure in this interim analysis.

BMD of the lumbar spine increased by 1.6% among the patients in the toremifene group, compared with a decrease in BMD of 0.7% among the patients in the placebo group (between-group comparison, P<.001).

Similar changes in BMD of the hip and femoral neck were observed. Specifically, BMD of the total hip increased 0.7% in the toremifene group and decreased 1.3% in the placebo group (P=.001); BMD of the femoral neck increased 0.2% in the toremifene group and decreased 1.3% in the placebo group (P=.009).

"Similar improvements in BMD were associated with significant decreases in fracture risk in postmenopausal women treated with raloxifene," the authors remarked.

These improvements translated into absolute between-group differences in BMD from baseline of 2.3% for lumbar spine, 2.0% for total hip, and 1.5% for femoral neck.

"Because low BMD independently predicts the fracture risk in men, these findings suggest that toremifene may decrease the fracture risk in men receiving ADT for prostate cancer by increasing BMD," the study authors wrote. "The final results of the ongoing, multicenter, Phase III, fracture prevention study in men with prostate cancer on ADT will establish the clinical efficacy of toremifene in this setting." (Smith MR, et al. J Urol 2008;179:152-155.)

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