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

This study is currently recruiting participants.
Verified February 2012 by GE Healthcare
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01530477
First received: February 6, 2012
Last updated: February 9, 2012
Last verified: February 2012
History of Changes
  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
Osteopenia

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

Resource links provided by NLM:

MedlinePlus related topics: Bone Density
U.S. FDA Resources

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Assessing precision of the DXA devices when scanning regions of interest [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    Assess short-term precision of Skeletal measurements for the Spine and single Femur regions of interest and Body Composition measurements for Total Body regions of interest


Secondary Outcome Measures:
  • Creation of an image gallery for subjective evaluation of images [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    Collect acquisition images from Skeletal (Spine/Femur) and Body Composition (Total Body) measurements for the purposes of creating an "image gallery" in order to subjectively evaluate image quality for the three DXA devices described above.


Estimated Enrollment: 180
Study Start Date: January 2012
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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 the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects).
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, and 60 will be measured on all three systems (total of evaluable 90 subjects).

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

Locations
United States, Colorado
Colorado Center for Bone Research Recruiting
Lakewood, Colorado, United States, 80337
Contact: Paul Miller, MD     303-980-9985 ext 314     cbrothers@centerforboneresearch.com    
Principal Investigator: Paul Miller, MD            
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
Last Updated: February 9, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 23, 2013