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Title: Yearly Infusions With Zoledronic Acid Reduce Risk of Fractures in Women With Osteoporosis Compared With Placebo. Presented at ACOG

"Yearly Infusions With Zoledronic Acid Reduce Risk of Fractures in Women With Osteoporosis Compared With Placebo. Presented at ACOG"

By Ed Susman SAN DIEGO, CA -- May 10, 2007 -- A 15-minute intravenous (IV) infusion of zoledronic acid (Zometa) appears sufficient to significantly prevent fractures in postmenopausal women with osteoporosis, doctors said here at the 55[^th annual clinical meeting of the American College of Obstetricians and Gynecologists (ACOG).

The three-year study enrolled 3,875 women with osteoporosis who were given the IV infusion of 5 mg of zoledronic acid at the start of the study, 12 months later and then a third infusion 24 months after baseline. An additional 3,861 women were also assigned to receive placebo.

"Compared to placebo, once-yearly infusion with Zometa for three years resulted in significant and sustained decreases in vertebral, hip and nonvertebral fractures," said Betty Chan, PharmD, regional scientific manager, Novartis Pharmaceutical Corporation, East Hanover, New Jersey, United States.

Dr. Chan demonstrated how the treatment resulted in about a 33% reduction in clinical fractures -- incidents that caused symptoms to patients. About 12.8% of the patients getting placebo had clinical fractures compared with 8.4% of patient on Zometa. That difference proved to be statistically significant at the P <.001 level, Dr. Chan reported in a poster presentation on May 9^th.

"We think that an annual treatment is more convenient for patients than having to get treated once a month or once a week with oral bisphosphonates," Dr. Chan said.

Although patients who had the infusions had significantly more heart rhythm abnormalities than placebo patients, Dr. Chan said there were no significant differences rates of stroke, heart attacks or cardiovascular deaths between the two patient groups.

Treatment with zoledronic acid was associated with significant increases in bone mineral density compared with placebo, she said. There was a 6.7% increased in bone mineral density in the lumbar spine, a 6.0% increase in the hip and a 5.1% increase at femoral neck, said Dr. Chan. All the differences were statistically significant at the P <.001, she said.

The study was sponsored by Novartis Pharma AG, Basel, Switzerland.

[Presentation title: Effect of Once-yearly Infusion of Zoledronic Acid 5 mg in Postmenopausal Women with Osteoporosis. Abstract 28 (May 9)]

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