Rapid and sustained influence of intravenous zoledronic Acid on course of pain and analgesics consumption in patients with cancer with bone metastases: a multicenter open-label study over 1 year.

BACKGROUND

Bone metastases might lead to severe bone pain, pathologic fractures, and hypercalcemia. Osteolytic destruction is caused by the activation of osteoclasts by release of tumor-derived stimulating factors. Bisphosphonates are known to inhibit osteoclast function and, therefore, to alleviate the adverse effects of tumor-induced bone resorption.

METHODS

We investigated the effects of zoledronic acid on bone pain and use of analgesic medication in 604 patients with cancer with bone metastases in an openlabel multicenter study over 1 year. Patients were treated with a maximum of 12 infusions (4 mg) every 3 or 4 weeks.

RESULTS

During treatment, the mean visual analog score value for pain (mm) decreased by 13.9 +/- 32.3 from 37.1 +/- 28.2 to 23.3 +/- 24.2 (P < .0001, t test, intent-to-treat population, n = 410) and the mean analgesic score decreased by 0.56 +/- 1.42 from 1.84 +/- 1.53 to 1.28 +/- 1.63 (P < .0001, t test). A statistically significant reduction in visual analog score pain could be observed within 1 week after initiation of treatment. Application of zoledronic acid was safe and well tolerated.

CONCLUSIONS

Treatment with zoledronic acid in patients with cancer with bone metastases in a broad range of tumor types provides substantial benefit in terms of pain relief.