Salivary-based Bone Loss Marker Detection Platform for Point-of-care Screening - Phase II Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 197
- 试验地点
- 1
- 主要终点
- Validation of human saliva sample analyzer LFA technique against measured bone density
研究概览
简要总结
The purpose of this study is to validate a human saliva sample analyzer technique designed to screen for low bone density and osteoporosis. The analyzer technique is meant to be a simple, noninvasive, easy-to-use, cost-effective, and routine means of diagnosing bone turnover using a point-of-care device that monitors salivary markers of bone turnover in a screening patient population that is at risk for low bone density or osteoporosis.
详细描述
Primary objective: To validate the performance of human saliva sample analyzer LFA technique against bone density as measured by quantitative computed tomography (QCT).
Secondary objective: To validate the performance of human saliva sample analyzer LFA technique against salivary ELISA method (gold standard).
Number of sites: Single site at the University of Mississippi Medical Center
The purpose of this prospective Phase II observational study is to further refine a proprietary device and test it in a screening population composed of women 50 years of age or older who are at risk for low bone density or osteoporosis (N=200). After screening for inclusion and exclusion criteria and obtaining informed consent, participants will provide a salivary sample and will undergo quantitative computed tomography (QCT) at the same visit (Visit 1, Day 0). No additional visits are planned. Bone mineral density (BMD) will be measured by diagnostic radiologists using QCT techniques and serve as the gold standard for the study. Salivary samples will be analyzed by a lab at UMMC for concentrations of osteocalcin (OC) and deoxypyridinoline (DPD) using enzyme-linked immunosorbent assay (ELISA) techniques, while blinded to BMD measurements. De-identified and coded salivary sample will be shipped to IOS who will measure concentrations of OC and DPD using lateral flow assay (LFA), while blinded to BMD measurements.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female ≥50 years of age and referred for standard of care screening mammogram.
- •Ability to provide salivary samples.
- •Ability to lie flat on the CT scanner.
- •Ability and willingness to provide signed and dated informed consent.
排除标准
- •Any known bone metabolism disorder (other than osteoporosis or low bone density) including sickle cell disease, current neoplastic disease, metastatic disease or any neoplastic disease involving the bones (including leukemia), or Paget's disease.
- •Body weight exceeds the weight limit (>400lbs) of the CT table.
- •Vulnerable subjects including pregnant women and prisoners.
- •Subjects who have had prior QCT imaging to measure bone density.
结局指标
主要结局
Validation of human saliva sample analyzer LFA technique against measured bone density
时间窗: 20 months
To validate the performance of human saliva sample analyzer LFA technique against bone density as measured by quantitative computed tomography (QCT).
次要结局
- Validation of human saliva sample analyzer LFA technique against ELISA (gold standard)(20 months)