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Agency for Healthcare Research Quality

Pharmaceutical Research

Study confirms link between intravenous bisphosphonates and jaw infection or surgery

Highly potent intravenous (IV) biphosphonates are used to treat cancer-related bone lesions, severe osteoporosis (thin and fragile bones), and other conditions. Although these medications reduce bone loss and fractures, they have been linked in small studies and case reports to the previously rare osteonecrosis (dissolution) of the jaw and facial bones.

A new study of 16,073 cancer patients confirms a strong link between IV bisphosphonate therapy and jaw inflammation and infection, as well as surgery of the jaw and facial bones. Researchers matched 28,598 bisphosphonate nonusers at a 2:1 ratio to 14,349 bisphosphonate users (pamidronate and/or zoledronic acid) between 1993 and 2003 based on cancer type, age, sex, risk factors for osteonecrosis (such as diabetes and smoking), bone metastasis, and geographic region. They followed patients until the end of 2003. Users of IV bisphosphonates had triple the risk of jaw or facial bone surgery than nonusers. They also had an 11.5-fold higher risk of being diagnosed with inflammatory conditions or infections of the jaw. In addition, IV bisphosphonate users had an absolute risk at 6 years for any jaw toxicity of 5.48 events per 100 patients compared with 0.30 events per 100 patients not using such drugs.

The risk of each adverse outcome increased as the medication dose increased. For example, 4 to 8 infusions increased the risk of jaw or facial bone surgery nearly fourfold, which jumped to ninefold for more than 21 infusions. The researchers suggest promoting oral hygiene and avoiding tooth extractions to avoid oral infections and jaw complications in patients on IV bisphosphonates.

The study was funded in part by the Agency for Healthcare Research and Quality (HS11618).

More details are in "Intravenous bisphosphonate therapy and inflammatory conditions or surgery of the jaw: A population-based analysis," by Gregg S. Wilkinson, Ph.D., Yong-Fang Kuo, Ph.D., Jean L. Freeman, Ph.D., and James S. Goodwin, M.D., in the July 4, 2007, Journal of the National Cancer Institute 99(13), pp. 1016-1024.

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