DXA Precision and Accuracy Comparison Study

Not Applicable

Terminated

• Conditions: Osteopenia

• 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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-06
• Study First Submitted QC: 2012-02-09
• Study First Posted: 2012-02-10
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2013-06-26
• Results First Submitted QC: 2014-09-23
• Results First Posted: 2014-09-25
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-08
• Last Update Posted: 2016-09-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 82

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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.

Trial Locations

Locations (1)

Colorado Center for Bone Research; 🇺🇸 Lakewood, Colorado, United States