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

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ClinicalTrials.gov Identifier: NCT01530477
Recruitment Status : Terminated (Early termination due to inability to meet enrollment for >350lb weight class)
First Posted : February 10, 2012
Results First Posted : September 25, 2014
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Tracking Information
First Submitted Date  ICMJE February 6, 2012
First Posted Date  ICMJE February 10, 2012
Results First Submitted Date  ICMJE June 26, 2013
Results First Posted Date  ICMJE September 25, 2014
Last Update Posted Date September 16, 2016
Study Start Date  ICMJE January 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 9, 2012)
Assessing precision of the DXA devices when scanning regions of interest [ Time Frame: up to 6 months ]
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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2012)
Creation of an image gallery for subjective evaluation of images [ Time Frame: up to 6 months ]
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DXA Precision and Accuracy Comparison Study
Official Title  ICMJE DXA Precision and Accuracy Comparison Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Osteopenia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.**

    Interventions:
    • Device: Lunar Prodigy (GEHC)
    • Device: Lunar iDXA (GEHC)
    • Device: Discovery A (Hologic
  • 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.**

    Interventions:
    • Device: Lunar Prodigy (GEHC)
    • Device: Lunar iDXA (GEHC)
    • Device: Discovery A (Hologic
  • 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.
    Interventions:
    • Device: Lunar Prodigy (GEHC)
    • Device: Lunar iDXA (GEHC)
    • Device: Discovery A (Hologic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 18, 2013)
82
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2012)
180
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01530477
Other Study ID Numbers  ICMJE 101.02-2011-GES-0005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GE Healthcare
Study Sponsor  ICMJE GE Healthcare
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul Miller, MD Study site
PRS Account GE Healthcare
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP