跳至主要内容
临床试验/NCT01747291
NCT01747291招募中不适用

Atypical Femur Fracture Ontario Cohort Registry

University Health Network, Toronto4 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2009年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
4
主要终点
Prospectively identify and diagnose atypical fracture patients in Ontario

研究概览

简要总结

Osteoporosis is a disease characterized by increased bone fragility and deteriorating bone micro-architecture. The main consequence of osteoporosis is low-trauma fractures, most often of the hip, spine and wrist. Recently, another type of low-trauma fracture, atypical femur fractures (AFFs), have received much attention. Little is known of the cause of these debilitating fractures; however, they have been associated with long term bisphosphonate use. What we currently know about AFFs is based on case reports or small case series, or studies using administrative databases or secondary analyses of bisphosphonate trials. While these reports provide some preliminary information on the relationship between long term bisphosphonate exposure and AFFs, detailed clinical data are absent. As we have established a network of specialists across southern Ontario our group is in a position to collect meaningful information on a larger group of patients who have experienced these debilitating fractures into a centralized AFF registry.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over the age of 20;
  • Patients who have experienced an incomplete AFF that satisfies the diagnostic criteria as set forth by the American Society of Bone and mineral Research (ASBMR) International Task Force on AFFs or a low (or no) trauma fracture that mimics the features described above at other sites.

排除标准

  • Peri-prosthetic fractures;
  • High trauma fractures;
  • Pathological fractures secondary to metastases or metabolic bone diseases other than osteoporosis.

结局指标

主要结局

Prospectively identify and diagnose atypical fracture patients in Ontario

时间窗: baseline

The objective of this exploratory study is to identify and diagnose AFF patients

次要结局

  • Examine risk factors and predictors for AFFs(baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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