DXA Precision and Accuracy Comparison Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Short Term Precision Comparison Across Three DXA Devices
研究概览
简要总结
This study is being conducted to examine the performance of three common DXA machines (1) Lunar iDXA, (2) Lunar Prodigy and (3) Hologic Discovery A in measuring bone density and body fat.
详细描述
For this study, two specific groups of volunteers will be recruited. In one group, the scan will measure bone density and in the other group the scan will measure fat. The groups will be broken into weight groups to determine which of the scanners the subject will be scanned on. Subjects will have the option to participate in either one or both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women > 20 years old
- •Willing to provide consent
- •Falls into one of three weight categories, with minimum 30 subjects per category.
- •Less than 200 lbs.
- •200 (inclusive) to less than 350 lbs.
- •350 (inclusive) to less than 450 lbs.
- •Participate in only one weight category in either skeletal or body composition cohort, or both.
排除标准
- •Inability to remain still for the duration of the DXA scans as judged by study Investigator.
- •Un-removable internal / external scan artifacts e.g. plaster casts, metal rodding naso-gastric tubes, etc.
- •Females of childbearing potential* with actual (confirmed by positive urine pregnancy test) or suspected (based on study Investigator evaluation despite a negative urine test) pregnancy.
- •Subject had already given consent to participate in any aspect of this study.
研究组 & 干预措施
Skeletal
Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)], and 60 will be measured on all three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)],(total of evaluable 90 subjects).
** Subjects can enroll in both Skeletal and Body Composition cohorts. Analysis will be performed within each cohort.**
干预措施: Lunar Prodigy (GEHC) (Device)
Skeletal
Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)], and 60 will be measured on all three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)],(total of evaluable 90 subjects).
** Subjects can enroll in both Skeletal and Body Composition cohorts. Analysis will be performed within each cohort.**
干预措施: Lunar iDXA (GEHC) (Device)
Skeletal
Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)], and 60 will be measured on all three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)],(total of evaluable 90 subjects).
** Subjects can enroll in both Skeletal and Body Composition cohorts. Analysis will be performed within each cohort.**
干预措施: Discovery A (Hologic (Device)
Body Composition
Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)], and 60 will be measured on all three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)], (total of evaluable 90 subjects).
** Subjects can enroll in both Skeletal and Body Composition cohorts. Analysis will be performed within each cohort.**
干预措施: Lunar Prodigy (GEHC) (Device)
Body Composition
Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)], and 60 will be measured on all three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)], (total of evaluable 90 subjects).
** Subjects can enroll in both Skeletal and Body Composition cohorts. Analysis will be performed within each cohort.**
干预措施: Lunar iDXA (GEHC) (Device)
Body Composition
Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)], and 60 will be measured on all three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)], (total of evaluable 90 subjects).
** Subjects can enroll in both Skeletal and Body Composition cohorts. Analysis will be performed within each cohort.**
干预措施: Discovery A (Hologic (Device)
Skeletal & Body Composition
"Skeletal and Body Composition" was not a cohort that was actively recruited to, it is a cohort for reporting purposes. Subjects will be measured on two of three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)]Subjects were able to consent and enroll to both Skeletal and Body Composition cohorts and these subjects will be counted for under this joint cohort.
干预措施: Lunar Prodigy (GEHC) (Device)
Skeletal & Body Composition
"Skeletal and Body Composition" was not a cohort that was actively recruited to, it is a cohort for reporting purposes. Subjects will be measured on two of three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)]Subjects were able to consent and enroll to both Skeletal and Body Composition cohorts and these subjects will be counted for under this joint cohort.
干预措施: Lunar iDXA (GEHC) (Device)
Skeletal & Body Composition
"Skeletal and Body Composition" was not a cohort that was actively recruited to, it is a cohort for reporting purposes. Subjects will be measured on two of three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)]Subjects were able to consent and enroll to both Skeletal and Body Composition cohorts and these subjects will be counted for under this joint cohort.
干预措施: Discovery A (Hologic (Device)
结局指标
主要结局
Short Term Precision Comparison Across Three DXA Devices
时间窗: Less than 6 months
BMD precision will be reported across three DXA devices in major skeletal and body composition sites. The short-term precision was calculated as RMS-SD (root mean square standard deviation) over the mean for each cohort. The skeletal cohort will not have short-term precision value for body composition indexes due to the different region of measurement. The same will apply to the body composition cohort. As the result, the "Skeletal \& Body Composition" cohort identified in participant flow and overall study summary will not have an analysis provided.
次要结局
未报告次要终点