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Efficacy and Safety of Ibandronate in the Treatment of Opioid-Resistant Bone Pain Associated With Metastatic Bone Disease: A Pilot Study

From the Supportive Care Clinic, Department of Internal Medicine, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium

Address reprint requests to Jean-Jacques Body, MD, PhD, Department of Internal Medicine, Université Libre de Bruxelles, 1 rue Heger-Bordet, Bruxelles 1000, Belgium; e-mail: jj.body{at}bordet.be

PURPOSE: Bone metastases are associated with severe and sometimes intractable pain, compromising patient quality of life (QOL). This open-label pilot study investigated the effects of short-term intensive treatment with intravenous (IV) ibandronate on opioid-resistant bone pain in patients with skeletal metastases.

PATIENTS AND METHODS: Eighteen patients with advanced tumors and metastatic bone disease received nonstandard treatment with 4 mg of ibandronate administered IV (2-hour infusion) for 4 consecutive days (16-mg total dose). Baseline opioid analgesic use was equivalent to 400 mg/d of morphine. Patients were assessed for 6 weeks or until death. Changes from baseline were determined for bone pain, opioid consumption, patient functioning, QOL, performance status, and biochemical markers of calcium metabolism and bone turnover. Renal function was assessed by serum urea and creatinine measurement.

RESULTS: Short-term, intensive ibandronate treatment significantly reduced bone pain scores within 7 days (P < .001). Pain reductions were sustained over the study period. Ibandronate significantly improved QOL, patient functioning, and performance status (P < .05). Mean values of the urinary cross-links pyridinoline and deoxypyridinoline tended to increase after day 21, returning close to baseline values by day 42. There was no correlation between the change in crosslinks values and the change in pain scores after ibandronate treatment. Ibandronate was well tolerated, with no evidence of renal toxicity.

CONCLUSION: Nonstandard, intensive treatment with IV ibandronate seems to have a marked analgesic effect in patients with opioid-resistant bone pain from metastatic bone disease. Further investigation is warranted.

The study and data analysis were supported by Foundation Medic and Les Amis de l'Institut Bordet.

Preliminary data from this study were previously reported in abstract form.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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