Precision and Reliability of Dual X-ray Absorptiometry (DXA) Testing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Precision of iDXA BMD
研究概览
简要总结
The purpose of the study is to assess precision of the GE Lunar iDXA, Hologic Horizon W DXA scanner, and the Stratec peripheral quantitative computed tomography (pQCT) scanner.
Aim 1: To assess standard deviation (SD) and coefficient of variation (CV) of testing bone mineral, bone geometry, and soft tissues in inanimate objects and adults. Tests on adults will be structured to assess:
- Within- and between-day variability of testing
- Within- and between-technician variability of testing
- Variability due to positioning and post-scan processing
- Variability due to different DXA scanning equipment
Aim 2: To assess the least significant change (LSC) for testing bone mineral and soft tissues in adults.
Aim 3: To assess strengths and limitations of DXA and pQCT testing, including sensitivity to movement, rate of re-rescanning, etc. which are crucial components for demonstrating feasibility in grant applications.
Aim 4: To construct a database of DXA and pQCT test results and quality control procedures, showing our laboratory's quality control level.
详细描述
Osteoporosis and obesity are highly prevalent and disabling chronic diseases. Osteoporosis is a disease of low bone mass, which predisposes people to bone fragility and increased risk of bone fractures. Obesity is a disease characterized by excess body fat levels, which predisposes people to diabetes, heart disease, stroke, hypertension, cancer, sleep apnea, osteoarthritis, and gallbladder disease.
An essential component to research on the prevention and treatment of osteoporosis and obesity is a valid method for monitoring body fat levels and bone mineral density. Dual energy X-ray absorptiometry (DXA) is a method for analyzing bone mineral density and body composition, particularly bone mineral content, fat mass and lean mass in children and adults. DXA scanners use an X-ray tube to produce radiation, which is then filtered into low- and high-energy beams. These beams of radiation are emitted from beneath a table that the supine human body is lying on. The arm, which passes above the person, detects the attenuation of the radiation for each pixel the body occupies. Based on known attenuation levels of different human tissues, the imaging software provides information on the composition of each pixel of the body. These pixels are then summed to provide information on: total body bone mineral content, total bone mineral density, fat mass, and lean mass. The DXA can also assess regional body composition (e.g. trunk fat), which is of importance in evaluating health effects of body fatness patterns. Using standard protocols, bone mineral content and density can be assessed in areas of the body indicating high risk of fractures (e.g. hip and lumbar spine) or areas that are likely to be responsive to dietary or physical activity manipulations (e.g. lumbar spine and radius).
Peripheral quantitative computed tomography (pQCT) is a 3-dimensional imaging technique that goes beyond the 2-dimensional imaging of DXA to assess both true volumetric bone density and bone geometry, the two key components of bone strength. Additionally, it can divide bone into its component parts, i.e. separately assessing bone density and bone geometry of cortical and trabecular bone. As such, the measurements obtained from pQCT provides a more complete picture of what may be occurring within bone tissue that contributes to either bone gain or bone loss, depending on the population and question of interest. pQCT assesses parameters of bone strength at the radius (forearm) and tibia (lower leg).
A vital component of any clinical and research program is precision testing, which assesses the reproducibility of DXA and pQCT measurements within an individual technician and/or between multiple technicians. This study was designed to address our facility's needs and ethical requirement to complete precision testing. This precision testing is a necessary component of verifying the feasibility and validity of the method, as well as cross-calibrating DXA scanners in our multi-site studies. We are completing this testing with the two DXA scanners, the GE Lunar iDXA and the Hologic Horizon W DXA, as well as with the Stratec XCT 3000 pQCT.
A vital component of any clinical and research program is precision testing, which assesses the reproducibility of DXA measurements within an individual technician and/or between multiple technicians. As alluded to above, the validity of bone and soft tissue measurements by DXA and pQCT is related to the skill of the technician in: 1) properly positioning the person before scanning and 2) properly analyzing the scan images afterward. Both of these components are subjective, requiring experience and feedback to improve technique.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults of two age groups, 1) aged 18-40 or 2) aged >40yr.
排除标准
- •for females, being pregnant
- •Having had X-ray procedures using contrast material in the previous 3 days
- •Having medical devices that interfere with scan accuracy
- •Wearing external metal objects that cannot be removed
- •Having internal metal objects
- •Body mass of > 450 lbs.
- •Having ostomies
研究组 & 干预措施
Men and women aged 18+
Men and women over the age of 18
干预措施: DXA and pQCT precision testing (Device)
结局指标
主要结局
Precision of iDXA BMD
时间窗: One month
Standard Deviation and coefficient of variation for BMD measurements obtained on the GE Lunar iDXA
Precision of Hologic Horizon W DXA BMD
时间窗: One month
Standard Deviation and coefficient of variation for BMD measurements obtained on the Hologic Horizon W
Precision of iDXA Body Composition
时间窗: One month
Standard Deviation and coefficient of variation for body composition measurements obtained on the GE Lunar iDXA
Precision of the Stratec XCT 3000 pQCT
时间窗: One month
Standard deviation and coefficient of variation for bone density, geometry, and estimated bone strength for the Stratec XCT 3000 pQCT
Precision of Hologic Horizon W DXA Body Composition
时间窗: One month
Standard Deviation and coefficient of variation for body composition measurements obtained on the Hologic Horizon W
次要结局
- LSC for the iDXA BMD(One month)
- LSC for the Hologic Horizon W body composition(One month)
- LSC for the Hologic Horizon W BMD(One month)
- LSC for the iDXA body composition(One month)
- LSC for the Stratec XCT 3000(One month)
研究者
Mary Jane DeSouza
Professor of Kinesiology
Penn State University
