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Title: Zoledronic Acid Protects Against Fractures in Patients With Renal Impairment: Presented at AACE
URL: http://www.pslgroup.com/dg/221C8A.htm
Doctor's Guide
May 22, 2008

By Ric Susman

ORLANDO, Fla -- May 21, 2008 -- Patients with renal impairment still can receive protection against fractures by taking courses of zoledronic acid, according to researchers presenting here at the American Association of Clinical Endocrinologists (AACE) 17th Annual Meeting and Clinical Congress.

"At 36 months, patients using zoledronic acid had a significantly reduced risk of morphometric vertebral fractures (P = .034)," said Paul D. Miller, MD, Clinical Professor of Medicine, University of Colorado Health Sciences Center, Denver, Colorado, in a poster presentation here May 17.

The aim of Dr. Miller's study was to determine whether the skeletal response to zoledronic acid is affected by the increased serum bisphosphonate levels that are apparent in patients with renal impairment.

Dr. Miller's team explored data from the Health Outcomes and Reduced Incidence With Zoledronic Acid Once Yearly (HORIZON) Pivotal Fracture trial. The 3-year multicentre, double-blind, randomised, placebo-controlled study of 7,736 postmenopausal women evaluated the safety and efficacy of once-yearly zoledronic acid 5 mg in the treatment of osteoporosis. The overall results of the main study demonstrated that this dose of zoledronic acid reduces the risk of vertebral fractures by 70% and hip fractures by 41%.

The subjects' ages varied from 65 to 89 years at randomisation, and they were separated into 2 strata. Group 1 consisted of 6,084 women who had no additional osteoporosis therapy; while group 2 was comprised of 1,652 women who did have additional osteoporosis therapy, including hormone therapy and other medications.

In this subgroup analysis, patients were divided into 2 groups: those with an estimated creatinine clearance >=60 mL/min at baseline and those with creatinine clearance <60 mL/min at baseline.

"There was a 30% to 40% increase in zoledronic acid levels … in patients with mild to moderate renal failure," Dr. Miller noted. "[But] there were [also] beneficial effects on skeletal response to treatment, demonstrated by normal bone histomorphometry, decreased biomarkers of bone turnover, increased bone-mineral density, and decreased risk of vertebral and hip fractures, regardless of baseline renal function."

Funding for this study was provided by Novartis Pharmaceuticals Corporation.


[Presentation title: The Skeletal Response to Zoledronic Acid Is Not Affected by Renal Impairment. Abstract 711]

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