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Intravenous Ibandronate May Be Associated With Higher Incidence of Flu-like Symptoms, Urinary Incontinence, and Other Side Effects: Presented at AACE

By John Otrompke

CHICAGO, I.L. -- May 1, 2006 -- While use of intravenous (IV) ibandronate may lead to a greater likelihood of developing an influenza-like illness, as well as other side effects, the it may nonetheless be preferable to oral bisphosphonate regimens for some post-menopausal patients with osteoporosis, including those who are bedridden or on multiple medications.

"It is estimated that between 1 and 1.5 million fractures occur in the United States each year, about 300,000 of which are hip fractures," said Keith E. Friend, MD, senior medical director, Roche Laboratories Inc, Nutley, New Jersey, United States.

IV ibandronate is generally well tolerated at either 2 mg every 2 months or 3 mg every 3 months, the researchers stated in their poster.

"This was not a fracture trial," Dr. Friend said. "With the original trial data, we actually looked for fractures proactively."

Clinical fractures, which when reported were categorized as an adverse event, were confirmed radiographically. At 2 years, 6.2% of patients had experienced a clinical fracture.

Other adverse events included influenza-like illness, seen in 4% and 3.8% of patients in the bi-monthly and tri-monthly groups, respectively, compared to 0.9% of the daily oral dose patients. One patient in the bi-monthly and 4 in the tri-monthly groups withdrew from the study due to these symptoms.

Among other adverse effects, urinary incontinence also increased in the tri-monthly IV group, with 1.3% of patients receiving 3 mg IV experiencing urinary incontinence, compared to 0.4% of the patients in the daily group.

Hypertension appeared to decrease among patients receiving the IV form (9.8%) compared to the daily dose group (11.6%), the poster said.

Deaths which occurred in the study were not thought to be treatment-related. Participants ranged from 55 to 80 years in age. Four deaths occurred in the daily oral dose population, compared to a total of 5 in the two IV groups, the poster said.


[Presentation title: Safety and Tolerability of Intravenous Ibandronate: One and two-Year Data From DIVA Study. Poster 309]

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