NCT01439139已完成不适用
Portable Bone Ultrasonometer for Osteoporosis Assessment
Artann Laboratories1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2011年9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
- 130
- 试验地点
- 1
- 主要终点
- BUSS data will be able to discriminate between postmenopausal women with osteoporosis compared with no osteoporosis defined by DXA measurements.
研究概览
简要总结
The aim of clinical study is to assess effectiveness of Bone UltraSonic Scanner (BUSS) versus densitometry (DXA) in osteoporosis detection.
详细描述
Study will conduct measurements in a group of postmenopausal women and use their DXA examination data as a control. BUSS data will be able to discriminate between postmenopausal women with osteoporosis compared with no osteoporosis defined by DXA measurements.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal
- •Age 50-90 years
- •Any race or ethnicity
- •DXA spine and hip exam within one year
排除标准
- •Open wounds or rashes on the testing area
- •Active skin infection
- •Recent tibia surgery
- •Abnormal tibia anatomy
- •Body Mass Index > 34.9 kg/m2
- •Current or previous tibial fracture on side of testing
- •Stroke or 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:
- •Bisphosphonates
- •Calcitonin
- •Estrogens or selective estrogen receptor modulator (SERM)
- •Therapeutic doses of fluoride (> 2mg/day)
- •Teriparatide used currently or within past 3 months
- •Drugs under research protocols, and
- •Unstudied or unapproved drugs
- •Presence of metabolic bone disease
结局指标
主要结局
BUSS data will be able to discriminate between postmenopausal women with osteoporosis compared with no osteoporosis defined by DXA measurements.
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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