Osteonecrosis of the Jaw in Non-Cancer Patients Using Bisphosphonates

描述（由申请人提供）：双膦酸盐是骨质疏松症最常见的治疗方法。在过去的几年里，越来越多的报告骨坏死的颌骨（ONJ）提出了相当大的关注，这些药物的长期安全性。这些病例报告给患者和临床医生关于骨质疏松症的最佳药物治疗带来了相当大的不确定性。颌骨骨坏死表现为口腔中暴露的疼痛或无痛区域，有时是感染的骨。其发病率、成本和理想的治疗方法尚不清楚。这项R21修订拨款提案将利用大型医疗保健利用数据库的统计能力来估计非癌症双膦酸盐使用者中ONJ的发病率。将通过初步病历审查确认无癌症的典型成人队列中的所有ONJ病例。将评估重要的患者亚组，包括既往拔牙或感染、合并使用糖皮质激素和特定共病的患者。将通过图表审查和医疗保健利用数据库的分析，评估与ONJ相关的临床病程和医疗保健支出。来自ONJ确诊病例的数据将形成该疾病的最大收集病例系列之一，允许评估ONJ不同治疗策略的有效性。该提案中的信息将回答有关双膦酸盐与ONJ之间相关性的直接问题，并将提供可用于设计未来治疗试验的重要数据。 公共卫生相关性：这项研究将评估患有骨质疏松症的双膦酸盐使用者中颌骨骨坏死的发病率和相对风险。数以百万计的美国人患有骨质疏松症，其中许多人正在使用双膦酸盐治疗这种疾病。通过更好地了解与这组药物相关的风险，骨质疏松症的药物治疗可能会受到实质性影响。

DESCRIPTION (provided by applicant): Bisphosphonates are the most common treatment for osteoporosis. In the last few years, increasing reports of osteonecrosis of the jaw (ONJ) have raised considerable concerns regarding the long-term safety of these agents. The case reports have created considerable uncertainty with patients and clinicians regarding the optimal pharmacotherapy for osteoporosis. Osteonecrosis of the jaw presents as a painful or painless area of exposed and sometimes infected bone in the oral cavity. Its morbidity, cost, and ideal treatment are not well understood. This R21 revised grant proposal will utilize the statistical power of large health care utilization databases to estimate the incidence of ONJ among users of bisphosphonates without cancer. All ONJ cases among a cohort of typical adults without cancer will be confirmed with primary chart review. Important subgroups of patients will be assessed including patients with prior dental extractions or infections, concomitant use of glucocorticoids, and specific comorbid illnesses. The clinical course and health care expenditures associated with ONJ will be assessed through chart review and analysis of the health care utilization database. Data from the confirmed cases of ONJ will form one of the largest collected case series of this condition, allowing assessment of the effectiveness of different treatment strategies for ONJ. Information from this proposal will answer immediate questions about the association between bisphosphonates and ONJ and will provide important data that can be used in designing future treatment trials for this condition. PUBLIC HEALTH RELEVANCE: The proposed research will estimate the incidence and relative risk of osteonecrosis of the jaw among bisphosphonate users with osteoporosis. Millions of Americans have osteoporosis and many of them are using bisphosphonates for this condition. Pharmacotherapy for osteoporosis may be substantially affected through a better understanding of risks associated with this group of medications.