DXA Precision and Accuracy Comparison Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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DXA Precision and Accuracy Comparison Study

Conditions
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Osteopenia

Intervention / Treatment
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* Device: Lunar Prodigy (GEHC)
* Device: Lunar iDXA (GEHC)
* Device: Discovery A (Hologic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skeletal<br>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.** | Device: Lunar Prodigy (GEHC)<br>* Lunar Prodigy (GEHC) used to obtain Skeletal, and/or Body Composition measurements<br>Device: Lunar iDXA (GEHC)<br>* Lunar iDXA (GEHC) used to obtain Skeletal, and/or Body Composition measurements<br>Device: Discovery A (Hologic<br>* Discovery A (Hologic) used to obtain Skeletal, and/or Body Composition measurements<br>|
| Experimental: Body Composition<br>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.** | Device: Lunar Prodigy (GEHC)<br>* Lunar Prodigy (GEHC) used to obtain Skeletal, and/or Body Composition measurements<br>Device: Lunar iDXA (GEHC)<br>* Lunar iDXA (GEHC) used to obtain Skeletal, and/or Body Composition measurements<br>Device: Discovery A (Hologic<br>* Discovery A (Hologic) used to obtain Skeletal, and/or Body Composition measurements<br>|
| Experimental: Skeletal & Body Composition<br>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. | Device: Lunar Prodigy (GEHC)<br>* Lunar Prodigy (GEHC) used to obtain Skeletal, and/or Body Composition measurements<br>Device: Lunar iDXA (GEHC)<br>* Lunar iDXA (GEHC) used to obtain Skeletal, and/or Body Composition measurements<br>Device: Discovery A (Hologic<br>* Discovery A (Hologic) used to obtain Skeletal, and/or Body Composition measurements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Term Precision Comparison Across Three DXA Devices | 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. | Less than 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone mineral density, weight, body composition, DEXA, DXA