Osteonecrosis of the Jaw in Non-Cancer Patients Using Bisphosphonates

描述（由申请人提供）：双膦酸盐是治疗骨质疏松症最常用的药物。在过去的几年中，越来越多的颌骨骨坏死（ONJ）的报道引起了对这些药物长期安全性的相当大的关注。病例报告造成了相当大的不确定性与患者和临床医生关于骨质疏松症的最佳药物治疗。颌骨骨坏死表现为口腔内暴露的骨头疼痛或无痛，有时受感染。其发病率、费用和理想的治疗方法尚不清楚。本R21修订拨款提案将利用大型卫生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的发生率。所有未患癌症的典型成人队列中的ONJ病例将通过初级图表回顾得到证实。将对重要的患者亚组进行评估，包括既往拔牙或感染、同时使用糖皮质激素和特定合并症的患者。将通过图表审查和卫生保健利用数据库的分析来评估与ONJ有关的临床过程和卫生保健支出。来自确诊ONJ病例的数据将构成该病症最大的收集病例系列之一，从而可以评估不同治疗策略对ONJ的有效性。该提案的信息将回答有关双膦酸盐和ONJ之间关系的直接问题，并将提供重要的数据，可用于设计该疾病的未来治疗试验。

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.