Deoxypyridinoline (Dpd), a crosslink product of collagen molecules found in bone and excreted in urine during bone degradation, has been described as a marker of bone turnover in metastatic breast cancer. In this study, the urine deoxypyridinoline/creatinine (Dpd/Cre) ratio was determined by enzyme immunoassay in urine samples from 116 women with breast cancer. Bone metastases were confirmed by x-ray or CT scan, with follow-up > 6 mo. The urine Dpd/Cre ratio was significantly higher in patients with bone metastasis, compared to those without bone metastasis (p < 0.05). In patients with bone metastasis, ratios of urine Dpd/Cre were higher in those with multiple lesions, compared to those with a solitary lesion, and the values also reflected therapeutic response (p < 0.05). Serial monitoring of urine Dpd/Cre revealed that an elevation was correlated with disease progression. Patients with stable bone disease under effective therapy had significant diminution of the urine Dpd/Cre ratios, compared to those with progression of bone disease (p < 0.05). In conclusion, the urine Dpd/Cre ratio may be a useful marker for detecting bone metastases and evaluating their response to therapy.