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Intravenous Form and Labeling Approved for Ibandronate: Presented at AACE

By John Otrompke

CHICAGO, I.L. -- May 1, 2006 -- Using changes in bone marrow density (BMD) as a proxy end-point for efficacy in reducing fractures among postmenopausal women, a study of intravenous (IV) ibandronate injections won FDA labeling approval for the new drug in an intravenous form.

"The FDA required fracture data for the daily oral dose when ibandronate was first approved about a year ago. But they said that if we showed that the effect of the intravenous form on bone marrow density was at least as good as the oral form, then we wouldn't have to do a fracture study," said Michael A. Bolognese, MD, medical director, Bethesda Health Research Center, Bethesda, Maryland, United States.

Based on the results of the phase 3 clinical trial, which evaluated 1395 patients, the FDA approved the IV form of the new bisphosphonate regimen in early 2006, Dr. Bolognese said.

IV bisphosphonate regimens may be more appropriate than oral treatments for some patients, according to the poster.

"There are a fair number of patients who have had bypass surgery, who can't take oral medications," Bolognese said. "You don't have to worry about the medicine getting lodged in the [gastrointestinal] tract and causing irritation, or about interactions with other medications, because the drug doesn't go to the liver in an intravenous form. And you get good compliance."

The study compared 1 and 2-year efficacy data from the Dosing for Intravenous Administration (DIVA) study. Patients were given either 2.5 mg orally per day, or 2 mg by IV administration every 2 months, or 3 mg IV every 3 months.

"We saw that in general, the intravenous form was not only as good as the daily dose for fractures, but that it performed better than the daily dose," Dr. Bolognese said.

The mean increase in lumbar spine BMD at 1 year was 5.1% in the group receiving IV ibandronate every 2 months and 6.4% in the every-3-months group, compared to 3.8% in the group receiving the daily oral dose, the poster said.


[Presentation title: Intravenous Ibandronate Injections in Postmenopausal Osteoporosis: Bone Marrow Density and Serum CTX Efficacy at 1 and 2 Years From DIVA Study. Poster 297]

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