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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:
ClinicalTrials.gov Identifier:
NCT01530477
First Posted: February 10, 2012
Last Update Posted: September 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GE Healthcare
  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: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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 ]
    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)
Arms Assigned Interventions
Experimental: 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
Experimental: 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
Experimental: 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01530477     History of Changes
Other Study ID Numbers: 101.02-2011-GES-0005
First Submitted: February 6, 2012
First Posted: February 10, 2012
Results First Submitted: June 26, 2013
Results First Posted: September 25, 2014
Last Update Posted: September 16, 2016
Last Verified: August 2016

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

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