Prevention of Bone Mineral Loss by Zoledronic Acid in Men with Prostate Carcinoma Receiving Androgen Deprivation Therapy: A Prospective Randomized Trial in an Indian Population

Abstract

Objective: To assess the efficacy of zoledronic acid in preventing bone mineral loss in locally advanced, non-metastatic prostate carcinoma in men receiving androgen deprivation therapy. Patients and Methods: Forty-one men with locally advanced, non-metastatic prostate carcinoma were randomly divided into 2 groups to receive zoledronic acid 4 mg intravenous infusion (n = 19) or a placebo (n = 22) every 3 months. The primary efficacy variables were measurement of bone mineral density (BMD) of the lumbar spine and urinary deoxypyridinoline at the baseline and at the end of treatment. The efficacy analysis was by mean and percent-age change of these variables from the baseline to the end of the treatment. Results: The mean BMD increased significantly to 1.18 g/cm² from a baseline value of 1.09 g/cm² in the zoledronic acid group. In the placebo group, the mean BMD decreased to 0.99 g/cm² from a baseline value of 1.07 g/cm². The percentage change of BMD of the lumbar spine from the baseline was an 8.15% increase in the zoledronic acid group and a 7.0% decrease in the placebo group. There was also a significant decrease of mean urinary deoxypyridi-noline values in the zoledronic acid group (p < 0.05) and a significant increase in the placebo group (p < 0.001). Conclusion: Long-term androgen deprivation therapy for prostate carcinoma patients leads to significant loss of bone density. Bisphosphonate treatment especially with the highly potent zoledronic acid should be considered in patients with a low BMD baseline because this drug not only prevents the decrease in BMD but also improves BMD.