Reducing skeletal complications and bone pain with intravenous ibandronate for metastatic bone disease

摘要

Complications of metastatic bone disease substantially compromise patient independence and mobility. The goals of management include reducing the rate of skeletal complications and alleviating bone pain, to improve morbidity and patient quality of life. In a 96-week, randomised, double-blind, phase III trial, intravenous (i.v.) ibandronate 6 mg administered over 1-2 h every 3-4 weeks significantly reduced skeletal complications (assessed by the skeletal morbidity period rate [SMPR]) compared with placebo (P=0.004). Individual components of the SMPR were also significantly reduced with ibandronate (vertebral fractures, P=0.023 and need for bone radiotherapy, P=0.011 versus placebo). Ibandronate 6 mg also significantly reduced bone pain scores and maintained them below baseline over 2 years (P<0.001), an effect not reported with other bisphosphonates for metastatic bone disease. Bone pain alleviation was accompanied by significantly improved quality of life compared with placebo (P=0.004). An independent pilot study used intensive i.v. ibandronate treatment (16 mg over 4 days) to treat opioid-resistant bone pain in patients with metastatic bone disease from various tumour types. Supporting the results of the phase III clinical trial, bone pain was significantly reduced (P<0.001 versus baseline), and patients experienced significant improvement in their quality of life (P<0.05 versus baseline). The results of these studies suggest that i.v. ibandronate effectively reduces skeletal morbidity rate and provides significant bone pain and quality of life benefits that have not been demonstrated so far with other bisphosphonates.