DXA Precision and Accuracy Comparison Study

Osteopenia Clinical Trial

— DXA P&A  

Official title:

DXA Precision and Accuracy Comparison Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01530477
• Other study ID #: 101.02-2011-GES-0005
• Status: Terminated
• Phase: N/A
• First received: February 6, 2012
• Last updated: November 15, 2015
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: November 2015
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 82
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteopenia

Intervention

Device:
• Lunar Prodigy (GEHC)
Lunar Prodigy (GEHC) used to obtain Skeletal, and/or Body Composition measurements
• Lunar iDXA (GEHC)
Lunar iDXA (GEHC) used to obtain Skeletal, and/or Body Composition measurements
• Discovery A (Hologic
Discovery A (Hologic) used to obtain Skeletal, and/or Body Composition measurements

Locations

Country	Name	City	State
United States	Colorado Center for Bone Research	Lakewood	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No