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

This study has been terminated.
(Early termination due to inability to meet enrollment for >350lb weight class)
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01530477
First received: February 6, 2012
Last updated: November 15, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention
Osteopenia
Device: Lunar Prodigy (GEHC)
Device: Lunar iDXA (GEHC)
Device: Discovery A (Hologic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: DXA Precision and Accuracy Comparison Study

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Short Term Precision Comparison Across Three DXA Devices [ Time Frame: Less than 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 82
Study Start Date: January 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Skeletal

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.**

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

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.**

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

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.
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The subject population sample will include approximately equal male/female split volunteers (no gender bias) from clinical practice patients.
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530477

Locations
United States, Colorado
Colorado Center for Bone Research
Lakewood, Colorado, United States, 80337
Sponsors and Collaborators
GE Healthcare
Investigators
Principal Investigator: Paul Miller, MD Study site
  More Information

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01530477     History of Changes
Other Study ID Numbers: 101.02-2011-GES-0005 
Study First Received: February 6, 2012
Results First Received: June 26, 2013
Last Updated: November 15, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by GE Healthcare:
Bone mineral density
weight
body composition
DEXA
DXA

ClinicalTrials.gov processed this record on February 10, 2016