DXA Precision and Accuracy Comparison Study (DXA P&A)

General Electric (GE)

Status: Terminated

Conditions: Osteopenia

Treatments: Device: Lunar Prodigy (GEHC); Device: Lunar iDXA (GEHC); Device: Discovery A (Hologic

Study type: Interventional

Funder types: Industry

Identifiers

NCT01530477

101.02-2011-GES-0005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Men and women > 20 years old

2. Willing to provide consent

3. 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.

4. Participate in only one weight category in either skeletal or body composition cohort, or both.

Exclusion criteria

1. Inability to remain still for the duration of the DXA scans as judged by study Investigator.
2. Un-removable internal / external scan artifacts e.g. plaster casts, metal rodding naso-gastric tubes, etc.
3. 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.
4. Subject had already given consent to participate in any aspect of this study.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 3 patient groups

Skeletal

Experimental group

Description:

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.\*\*

Treatment:

Device: Lunar Prodigy (GEHC)

Device: Lunar iDXA (GEHC)

Device: Discovery A (Hologic

Body Composition

Experimental group

Description:

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.\*\*

Treatment:

Device: Lunar Prodigy (GEHC)

Device: Lunar iDXA (GEHC)

Device: Discovery A (Hologic

Skeletal & Body Composition

Experimental group

Description:

"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.

Treatment:

Device: Lunar Prodigy (GEHC)

Device: Lunar iDXA (GEHC)

Device: Discovery A (Hologic