Age Dependend Diagnostic Thresholds for Osteoporosis Bindex Ultrasonometer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 560
- 试验地点
- 1
- 主要终点
- Thresholds for Bindex in Osteoporosis Diagnostics
研究概览
简要总结
This study is designed for clinical validation of the novel ultrasound device (Bindex®, Bone Index Finland Ltd.). In a preliminary study technique has been validated in Finnish elderly woman population with 285 healthy and 56 osteoporotic subjects (n = 341 in total). Significant and good correlation was observed between Density Index (DI) determined with Bindex and femoral bone mineral density determined with DXA (r = 0.65 - 0.70). In addition, with determination of 90% sensitivity and specificity thresholds, significant number (65-75%) of patients could be diagnosed without additional verification with DXA.
First, the thresholds for DI will be determined by measuring 70 osteoporotic and 70 healthy patients (n = 140) with Bindex and DXA within four decades of age; age 50 to 59 years, age 60 to 69 years, age 70 to 79 years, and age 80 to 89 years. The feasibility of DI for diagnostics of osteoporosis and evaluation of bone mineral density (BMD) will be assessed. The thresholds for the BMD estimate obtained with DI will be determined for osteoporotic and non-osteoporotic patients. For fracture risk assessment, DI measurements are used to predict the outcome of currently available fracture risk assessment tools.
- To investigate optimal configuration of ultrasound parameters and patient characteristics for prediction of proximal femur and lumbar spine BMD for women in each four decades of age; 50 to 59 years, 60 to 69 years, 70 to 79 years, and 80-89 years.
- To develop national diagnostic thresholds for DI in prediction of osteoporosis status with a reference female population (American-Caucasian) in each four decades of age; 50 to 59 years, 60 to 69 years, 70 to 79 years, and 80-89 years.
详细描述
Data will be stored by Park Nicollet Institute. Only data listed below will be given to the research team at Bindex for analyses.
The data for determination of diagnostic threshold for DI in North American population will be analyzed by Bone Index Finland. The data will include following parameters:
- Age in years
- Weight
- Height
- Cortical thickness values at each location
- Density Index values
- Raw data on ultrasound signals.
- DXA measurement data
- Identification code (Uniquely created identification code given to a subject, does not carry any information on subject but enables tracing if needed.)
- Data from Appendix A, excluding patient name and medical record number
Risk factors will be collected in a separate questionnaire (Appendix A).
- Name
- Medical Record Number
- Weight (kg)
- Height (cm)
- Chair Stand test Can do easily; can do only with difficulty; cannot do
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female sex
- •Age 50 to 89 years
排除标准
- •Those who have opted out of being contacted for research on their general Park Nicollet clinic consent will not be recruited by mail
- •Inability to sign consent form due to cognitive impairment. Those with dementia (ICD-9 diagnosis codes 331.0, 294.1, 294.10, 294.11, or 294.8) will excluded from mailed recruitment
- •Measurement of hip BMD is not feasible (for example, those who have had bilateral hip replacement surgeries or who cannot have central DXA because of their body weight)
- •Open leg or arm wounds at sites where ultrasound measurements are supposed to be taken, precluding such measurements
结局指标
主要结局
Thresholds for Bindex in Osteoporosis Diagnostics
时间窗: 1 year
Diagnostics thresholds for DI parameter for Osteoporosis within four decades of age; age 50 to 59 years, age 60 to 69 years, age 70 to 79 years, and age 80 to 89 years.
次要结局
未报告次要终点