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IV Ibandronate Injections Show Favourable Renal Tolerability in Postmenopausal Women: Presented at AACE

By Maribeth Stephens

SEATTLE, WA -- April 16, 2007 -- The effect of IV ibandronate injections in postmenopausal women with normal renal function or mild to moderate renal impairment is comparable with placebo and daily oral ibandronate, according to findings presented here at the American Association of Clinical Endocrinologists 16^th Annual Meeting and Clinical Congress (AACE).

Mike Lewiecki, MD, clinical faculty, department of medicine, University of New Mexico School of Medicine, Albuquerque, New Mexico, said that the data, "-- give us a higher level of confidence that we can safely give [IV ibandronate] to patients as long as it's given over the appropriate injection time period."

Dr. Lewiecki and colleagues noted that there is potential for renal toxicity with the use of IV bisphosphonates because they are not metabolised and are excreted by the kidney. "Renal toxicity has been observed with some IV bisphosphonates, particularly when they're given at too fast an infusion," he said. "Now there's considerable interest in re-evaluating the renal safety profile of all bisphosphonates, in particular injectable bisphosphonates."

To evaluate the renal safety profile of intermittent IV ibandronate injection in women with postmenopausal osteoporosis, the researchers pooled renal safety data from 4 randomised, double-blind, placebo-controlled trials. In the studies, women with postmenopausal osteoporosis received 1 of 3 regimens for up to 3 years: IV ibandronate injections 0.25 to 3.0 mg over 15 to 30 seconds every 2 or 3 months; 2.5 mg daily oral ibandronate; placebo.

In this pooled analysis, 3,295 patients received IV ibandronate, 1,442 received daily oral ibandronate, and 2,078 patients received placebo.

The incidence of adverse renal events among patients receiving IV ibandronate was 2.5% to 5.6%. Adverse renal events among patients receiving oral daily ibandronate was 5.3%, and in those receiving placebo the rate of adverse renal events was 3.7%.

There were no cases of acute renal failure. Mean creatinine clearance in patients who received IV ibandronate remained stable compared with the baseline and was similar to the rate of clearance among patients receiving oral ibandronate or placebo.

"With all the different doses of ibandronate that were given IV, from 2 to 12 mg, the change in creatinine clearance was no different than placebo and no different than oral ibandronate," said Dr. Lewiecki.

The investigators concluded that, in this analysis, when administered to postmenopausal women with normal renal function or mild or moderate renal impairment, IV ibandronate has a renal tolerability profile similar to oral ibandronate and placebo.


[Presentation title: Intravenous Ibandronate Injections Demonstrate Favourable Renal Tolerability. Abstract 297]

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