Columbia University, College of Physicians and Surgeons, PH 8 West 864, 630 West 168th Street, New York, NY 10032, USA.
J Bone Miner Res. 2010 Nov;25(11):2267-94. doi: 10.1002/jbmr.253.
Reports linking long-term use of bisphosphonates (BPs) with atypical fractures of the femur led the leadership of the American Society for Bone and Mineral Research (ASBMR) to appoint a task force to address key questions related to this problem. A multidisciplinary expert group reviewed pertinent published reports concerning atypical femur fractures, as well as preclinical studies that could provide insight into their pathogenesis. A case definition was developed so that subsequent studies report on the same condition. The task force defined major and minor features of complete and incomplete atypical femoral fractures and recommends that all major features, including their location in the subtrochanteric region and femoral shaft, transverse or short oblique orientation, minimal or no associated trauma, a medial spike when the fracture is complete, and absence of comminution, be present to designate a femoral fracture as atypical. Minor features include their association with cortical thickening, a periosteal reaction of the lateral cortex, prodromal pain, bilaterality, delayed healing, comorbid conditions, and concomitant drug exposures, including BPs, other antiresorptive agents, glucocorticoids, and proton pump inhibitors. Preclinical data evaluating the effects of BPs on collagen cross-linking and maturation, accumulation of microdamage and advanced glycation end products, mineralization, remodeling, vascularity, and angiogenesis lend biologic plausibility to a potential association with long-term BP use. Based on published and unpublished data and the widespread use of BPs, the incidence of atypical femoral fractures associated with BP therapy for osteoporosis appears to be very low, particularly compared with the number of vertebral, hip, and other fractures that are prevented by BPs. Moreover, a causal association between BPs and atypical fractures has not been established. However, recent observations suggest that the risk rises with increasing duration of exposure, and there is concern that lack of awareness and underreporting may mask the true incidence of the problem. Given the relative rarity of atypical femoral fractures, the task force recommends that specific diagnostic and procedural codes be created and that an international registry be established to facilitate studies of the clinical and genetic risk factors and optimal surgical and medical management of these fractures. Physicians and patients should be made aware of the possibility of atypical femoral fractures and of the potential for bilaterality through a change in labeling of BPs. Research directions should include development of animal models, increased surveillance, and additional epidemiologic and clinical data to establish the true incidence of and risk factors for this condition and to inform orthopedic and medical management.
长期使用双膦酸盐(BPs)与股骨非典型骨折相关的报告促使美国骨骼与矿物质研究学会(ASBMR)领导层任命一个工作组来解决与该问题相关的关键问题。一个多学科专家组审查了与非典型股骨骨折相关的已发表报告以及临床前研究,这些研究可以深入了解其发病机制。制定了病例定义,以便随后的研究报告相同的病症。工作组定义了完全性和不完全性非典型股骨骨折的主要和次要特征,并建议所有主要特征,包括其在转子下区域和股骨干的位置、横向或短斜向取向、最小或无相关创伤、当骨折完全时内侧的刺、无粉碎,都存在指定股骨骨折为非典型。次要特征包括其与皮质增厚、外侧皮质骨膜反应、前驱疼痛、双侧性、延迟愈合、合并症以及同时使用药物的关联,包括 BPs、其他抗吸收剂、糖皮质激素和质子泵抑制剂。评估 BPs 对胶原交联和成熟、微损伤和晚期糖基化终产物积累、矿化、重塑、血管生成和血管生成的影响的临床前数据为长期 BPs 使用与该疾病之间的潜在关联提供了生物学上的合理性。基于已发表和未发表的数据以及 BPs 的广泛使用,与骨质疏松症的 BP 治疗相关的非典型股骨骨折的发生率似乎非常低,尤其是与 BPs 预防的椎体、髋部和其他骨折数量相比。此外,尚未建立 BPs 与非典型骨折之间的因果关系。然而,最近的观察结果表明,随着暴露时间的延长,风险会增加,并且人们担心缺乏意识和漏报可能掩盖了该问题的真实发生率。鉴于非典型股骨骨折的相对罕见性,工作组建议创建特定的诊断和程序代码,并建立一个国际登记处,以促进对这些骨折的临床和遗传风险因素以及最佳手术和医疗管理的研究。应通过改变 BPs 的标签,使医生和患者意识到非典型股骨骨折的可能性以及双侧性的可能性。研究方向应包括开发动物模型、增加监测以及增加流行病学和临床数据,以确定该病症的真实发生率和风险因素,并为矫形和医疗管理提供信息。