Osteonecrosis of the Jaw in Non-Cancer Patients Using Bisphosphonates

描述(申请人提供)：双膦酸盐是治疗骨质疏松症最常见的治疗方法。在过去的几年里，越来越多的关于颌骨坏死(ONJ)的报道已经引起了人们对这些药物的长期安全性的相当大的关注。病例报告给患者和临床医生带来了相当大的不确定性，无法确定治疗骨质疏松症的最佳药物疗法。颌骨坏死表现为口腔中暴露的或有时感染的骨的疼痛或无痛性区域。它的发病率、成本和理想的治疗方法还不是很清楚。这份R21修订的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磷酸盐使用者中ONJ的发病率。一组典型的非癌症成年人中的所有ONJ病例将通过初步图表审查得到确认。重要的患者亚组将被评估，包括既往拔牙或感染、伴随使用糖皮质激素的患者以及特定的并存疾病。将通过对卫生保健利用数据库的图表审查和分析来评估与ONJ相关的临床病程和卫生保健支出。来自ONJ确诊病例的数据将形成这种疾病最大的收集病例系列之一，从而能够评估ONJ不同治疗策略的有效性。这项提案的信息将立即回答有关双膦酸类和ONJ之间的联系的问题，并将提供重要的数据，可用于设计这种疾病的未来治疗试验。 公共卫生相关性：拟议的研究将评估患有骨质疏松症的双磷酸盐使用者的颌骨骨坏死的发生率和相对风险。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来治疗这种疾病。通过更好地了解与这类药物相关的风险，骨质疏松症的药物治疗可能会受到很大影响。

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.