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临床试验/NCT00601068
NCT00601068已完成不适用

Proposal For The Development Of A Well Defined Database For Patients With Oral Bisphosphonate-Related Osteonecrosis of the Jaws (BON)

University of Florida1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2007年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
establish complete database and publish descriptive paper

研究概览

简要总结

In cooperation with Merck & Co, Inc. we will identify and form a database of 35 patients who have developed osteochemonecrosis of the jaws related to oral bisphosphonate use. We will study the triggers, associated medical conditions and medications, location of the lesion(s), and patient outcomes.

详细描述

This study is an observational study, and not a comparative trial. The major outcome is represented by the fraction of subjects with long term healed lesions.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
30 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Exposed bone in the oral cavity of greater than 6-8 weeks duration unresponsive to therapy

排除标准

  • Pregnant patients
  • Patients less than 30 yrs of age or greater than 90 yrs of age
  • Mentally incompetent individuals

结局指标

主要结局

establish complete database and publish descriptive paper

时间窗: 2 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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