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A medical claims study of 714,217 people

Background. While osteonecrosis of the jaw (ONJ) has been associated with the prolonged use of bisphosphonates (BPs), there is limited information about the risk of ONJ among users of oral BPs or about the magnitude of the risk among users of intravenous (IV) BPs.

Methods. The authors studied medical claims data from 714,217 people with osteoporosis or cancer to identify diagnostic codes or procedure codes for three outcomes: inflammatory conditions of the jaws, including osteonecrosis; major jaw surgery necessitated by necrotic or inflammatory indications; and jaw surgeries necessitated by a malignant process. The authors calculated stratified odds ratios and 95 percent confidence intervals.

Results. The results indicate that oral administration of BPs decreases the risk of adverse bone outcomes. In contrast, IV administration strongly and significantly increases the risk (P < .05) of adverse jaw outcomes or surgery. Across both osteoporosis and cancer, patients receiving IV BPs had a fourfold increased risk of having inflammatory jaw conditions and a greater than sixfold increased risk of having undergone major surgical resection in the jaw.

Conclusions. Mode of bisphosphonate use results in different risk profiles for adverse jaw outcomes. While the authors documented an increased risk of inflammatory conditions and surgical procedures of the jaw for users of IV BPs, they did not find these observed increases for users of oral BPs.

Clinical Implications. Physicians and dentists must be aware of the higher frequency of adverse jaw effects in patients receiving IV BPs, especially osteonecrosis of the jaw. While the authors’ results have internal consistency, more clinical studies are needed to replicate and clarify the observed associations over long follow-up periods.

Key Words: Adverse effect; alendronate; bisphosphonates; cancer; drug safety; medical claims; osteonecrosis of the jaw; osteoporosis; pamidronate; surveillance; zoledronic acid

Abbreviations: BPs: Bisphosphonates • CPT: Current Procedural Terminology • FDA: Food and Drug Administration • ICD-9: International Classification of Diseases, ninth revision • IV: Intravenous • NADP: National Association of Dental Plans • ONJ: Osteonecrosis of the jaw

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