Biomarker Identification in Orthopaedic and Oral Maxillofacial Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 314
- 试验地点
- 1
- 主要终点
- Absorption, Distribution, Metabolism, Excretion (ADME) Profiling of DNA from all sample types vs. normative data for the ADME panel and across study groups
研究概览
简要总结
Bisphosphonates are drugs that prevent bone loss by blocking the activity of cells that normally resorb bone. The most common examples of these drugs are Boniva and Fosamax. These drugs are available for oral or intravenous dosing and are prescribed at daily, weekly, biweekly, or monthly intervals. Among the many thousands of individuals who currently take these medications, certain individuals experience "atypical" femur fractures preceded by prodromal pain, changes in cortical thickening of bone, or bisphosphonate related osteonecrosis of the jaws (BRONJ). Osteonecrosis of the jaws is defined as exposed bone of the jaws for 8 weeks or more and requires surgical treatment.
This study will attempt to identify genomic and rna biomarkers that may play a role in differential metabolism of bisphosphonates or indicate tendency toward the severe adverse events associated with these drugs.
详细描述
Collected specimens were subjected to Affymetrix DMET™ Plus Solution analysis. Manuscript is in preparation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any adult (male or female) age 18 or over meeting any of the following criteria:
- •All participants must be able to provide informed consent for themselves.
- •History of BP treatment with or without BRONJ and/or Femur fracture (typical or atypical)
- •No History of BP treatment with or without BRONJ and/or Femur fracture (typical or atypical)
排除标准
- •Children age 17 or younger
- •Adults who cannot or do not make medical decisions for themselves
- •Persons known to be under the jurisdiction of the Department of Corrections
- •Individuals who are pregnant.
结局指标
主要结局
Absorption, Distribution, Metabolism, Excretion (ADME) Profiling of DNA from all sample types vs. normative data for the ADME panel and across study groups
时间窗: Baseline
DNA analysis of saliva, blood, and tissues to detect differential response to drugs. DNA will be isolated from each sample and ADME profiling will be performed. Each participant subgroup will be compared to each other using ANOVA modeling. Each participant subgroup will be compared to normative data for the distribution of gene profiles in the general population for each probe on the ADME gene array.
次要结局
- Differential expression of miRNA biomarkers across participant groups within the study(Baseline)