Back to resultsDXA Precision and Accuracy Comparison Study (DXA P&A)
Primary Purpose
Osteopenia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lunar Prodigy (GEHC)
Lunar iDXA (GEHC)
Discovery A (Hologic
Sponsored by
About this trial
This is an interventional screening trial for Osteopenia focused on measuring Bone mineral density, weight, body composition, DEXA, DXA
Eligibility Criteria
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.
Sites / Locations
- Colorado Center for Bone Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Skeletal
Body Composition
Skeletal & Body Composition
Arm 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.**
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 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01530477
Brief Title
DXA Precision and Accuracy Comparison Study
Acronym
DXA P&A
Official Title
DXA Precision and Accuracy Comparison Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
Early termination due to inability to meet enrollment for >350lb weight class
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GE Healthcare
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia
Keywords
Bone mineral density, weight, body composition, DEXA, DXA
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Skeletal
Arm Type
Experimental
Arm 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.**
Arm Title
Body Composition
Arm Type
Experimental
Arm 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.**
Arm Title
Skeletal & Body Composition
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Lunar Prodigy (GEHC)
Intervention Description
Lunar Prodigy (GEHC) used to obtain Skeletal, and/or Body Composition measurements
Intervention Type
Device
Intervention Name(s)
Lunar iDXA (GEHC)
Intervention Description
Lunar iDXA (GEHC) used to obtain Skeletal, and/or Body Composition measurements
Intervention Type
Device
Intervention Name(s)
Discovery A (Hologic
Intervention Description
Discovery A (Hologic) used to obtain Skeletal, and/or Body Composition measurements
Primary Outcome Measure Information:
Title
Short Term Precision Comparison Across Three DXA Devices
Description
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.
Time Frame
Less than 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Miller, MD
Organizational Affiliation
Study site
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colorado Center for Bone Research
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80337
Country
United States
12. IPD Sharing Statement
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DXA Precision and Accuracy Comparison Study
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