DXA Precision and Accuracy Comparison Study

Not Applicable

Terminated

Conditions: Osteopenia

Interventions: Device: Lunar Prodigy (GEHC)
Device: Lunar iDXA (GEHC)
Device: Discovery A (Hologic

Registration Number: NCT01530477

Lead Sponsor: GE Healthcare

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 82

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Skeletal	Lunar Prodigy (GEHC)	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.\\
Skeletal	Discovery A (Hologic	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.\\
Skeletal	Lunar iDXA (GEHC)	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.\\
Body Composition	Lunar iDXA (GEHC)	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.\\
Skeletal & Body Composition	Lunar iDXA (GEHC)	"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.
Body Composition	Lunar Prodigy (GEHC)	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.\\
Skeletal & Body Composition	Lunar Prodigy (GEHC)	"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.
Body Composition	Discovery A (Hologic	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.\\
Skeletal & Body Composition	Discovery A (Hologic	"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.

Primary Outcome Measures

Name	Time	Method
Short Term Precision Comparison Across Three DXA Devices	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.

Secondary Outcome Measures