Pamidronate to prevent bone loss during androgen-deprivation therapy for prostate cancer.

Background: Treatment with a gonadotropin-releasing hormone agonist decreas es bone mineral density and increases the risk of fracture in men with pros tate cancer. We conducted a controlled study of the prevention of osteoporo sis in men undergoing treatment with a gonadotropin-releasing hormone agoni st. Methods: In a 48-week, open-label study, we randomly assigned 47 men with a dvanced or recurrent prostate cancer and no bone metastases to receive eith er leuprolide alone or leuprolide and pamidronate (60 mg intravenously ever y 12 weeks). Bone mineral density of the lumbar spine and the proximal femu r was measured by dual-energy x-ray absorptiometry. Trabecular bone mineral density of the lumbar spine was measured by quantitative computed tomograp hy. Forty-one men completed the study. Results: In men treated with leuprolide alone, the mean (+/-SE) bone minera l density decreased by 3.3+/-0.7 percent in the lumbar spine, 2.1+/-0.6 per cent in the trochanter, and 1.8+/-0.4 percent in the total hip, and the mea n trabecular bone mineral density of the lumbar spine decreased by 8.5+/-1. 8 percent (P<0.001 for each comparison with the base-line value). In contra st, the mean bone mineral density did not change significantly at any skele tal site in men treated with both leuprolide and pamidronate. There were si gnificant differences between the two groups in the mean changes in bone mi neral density at 48 weeks in the lumbar spine (P<0.001), trochanter (P=0.00 3), total hip (P=0.005), and trabecular bone of the lumbar spine (P=0.02). Conclusions: Pamidronate prevents bone loss in the hip and lumbar spine in men receiving treatment for prostate cancer with a gonadotropin-releasing h ormone agonist. (N Engl J Med 2001;345:948-55.) Copyright (C) 2001 Massachu setts Medical Society.