NCT01056432已完成不适用
Phase I Study of Portable Bone Ultrasonometer for Osteoporosis Assessment
Artann Laboratories1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To obtain clinical data which will help to optimize the BUSS examination procedure and its diagnostic algorithms for assessment of bone conditions.
研究概览
简要总结
The aim of this clinical study using Bone UltraSonic Scanner (BUSS) is to obtain clinical data which will help to optimize the BUSS examination procedure and its diagnostic algorithms for assessment of bone conditions.
详细描述
The specific aims of this clinical study are:
- To optimize the data collection technique and establish an examination procedure;
- To collect data necessary for assessing the performance of BUSS sensors;
- To evaluate the probe ergonomic design and participant tolerance to probe application;
- To assess the clinical suitability of the software interface in data collection;
- To adjust the BUSS diagnostic algorithms using dual-energy X-ray absorptiometry (DEXA) data as a "gold" standard in osteoporosis detection and characterization;
- To evaluate BUSS performance including ease of use and consistency.
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
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any race or ethnical group DEXA examination scheduled within next two weeks or DEXA examination was completed within the last six months adn DEXA results are available
排除标准
- •Open wounds or rashes on the tibial testing area Active skin infection Recent tibia surgery Abnormal tibia Anatomy Current or previous tibial fracture Body Mass Index >34.9 Hyperparathyroidism or hypoparathyroidism within 5 years Osteitis deformans Renal osteodystrophy Osteomalacia Stroke with total or partial paralysis with residual disability lasting more than 3 months Current or recent (within past 6 months) use of bone-active drugs Drugs under research protocols Chronic use of over the counter antacids
结局指标
主要结局
To obtain clinical data which will help to optimize the BUSS examination procedure and its diagnostic algorithms for assessment of bone conditions.
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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