Renal tolerability of intermittent intravenous ibandronate treatment for patients with postmenopausal osteoporosis: a review

Abstract

While intravenous (IV) bisphosphonates are well established in managing metastatic bone disease and hypercalcemia of malignancy, oral bisphosphonates are the primary treatment for postmenopausal osteoporosis. The availability of a well-tolerated, effective, IV bisphosphonate regimen for postmenopausal osteoporosis would increase physicians' options, allowing treatment of patients who cannot tolerate oral therapy, for whom oral bisphosphonates should be avoided or patients who are unable to comply with the oral dosing recommendations. Ibandronate is a potent, nitrogen-containing bisphosphonate, with proven efficacy and good tolerability when administered intermittently either orally or intravenously. Preclinical experience in animal models with IV ibandronate indicated that it had good renal tolerability. These data are supported by clinical pharmacology studies. Prolonged follow-up of patients receiving intermittent IV 15-30 second injections of 0.5-3 mg IV ibandronate has demonstrated no clinical evidence of renal toxicity in patients with postmenopausal osteoporosis. What is seen in controlled studies is not always the case in uncontrolled studies, however, no reports of renal failure have been received in post-marketing surveillance of >500,000 patients receiving IV ibandronate infusions in various indications including metastatic breast and prostate cancer. The good renal tolerability of IV ibandronate in patients with osteoporosis with glomerular filtration rates >30 mL/minute and without renal co-morbid conditions is reassuring.