The aim of our study was to assess the clinical efficacy and toxicity of ibandronate in the management of symptomatic skeletal metastases due to prostate cancer (PCA). Twenty-five patients with painful osseous metastases due to hormone refractory PCA (HRPCA) were treated with 6 mg ibandronate every 4 weeks in an open prospective non-randomized clinical study. Primary study endpoint was pain reduction documented by the use of a 10-point visual analog scale. Palliative response with significant reduction in pain score from 6.5 (5 -10) to 2.0 [(0 -4), P < 0.001] was achieved in 23 (92%) patients; nine patients (39%) were completely pain free. Bisphosphonate treatment of painful osseous metastases due to HRPCA resulted in a significant pain reduction and a significant decrease of daily consumption of analgesics in 92% of the patients. Both characteristics are paralleled by an increase in Karnofsky index mainly due to better mobility. Bisphosphonates should have a definite role in the palliative management of symptomatic HRPCA.
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