NCT01123421已完成不适用
Portable Ultrasonometer for Osteoporosis Assessment: Retrospective Fracture Risk Validation Study, Version #1
Artann Laboratories1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2010年5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
- 113
- 试验地点
- 1
- 主要终点
- Determine whether BUSS testing is equivalent or superior to DXA for fracture risk assessment in postmenopausal women.
研究概览
简要总结
Study to demonstrate that the Bone UltraSonic Scanner (BUSS) can aid in detection of osteoporosis and predict prevalent osteoporotic fractures. Measurements derived from the BUSS parameters will be able to discriminate between postmenopausal women with osteoporotic fractures when compared to matched controls without history of osteoporotic fracture.
详细描述
One of several studies to develop and clinically validate a novel ultrasonographic device, BUSS, for the assessment of osteoporosis and fracture risk.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •postmenopausal women with osteoporotic fracture at spine or wrist
- •postmenopausal women no history of fracture at spine or wrist
排除标准
- •women with a history of metabolic disease
- •tibia fracture or surgery
- •BMI ≥ 35 kg/m2
- •Teriparatide use currently or within the past 6 months,
- •Any skin issues (open wounds or rashes, and/or skin infections) of the tibial area.
结局指标
主要结局
Determine whether BUSS testing is equivalent or superior to DXA for fracture risk assessment in postmenopausal women.
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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