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

August 8, 2016 updated by: GE Healthcare
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Lakewood, Colorado, United States, 80337
        • Colorado Center for Bone Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Less than 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GE Healthcare

Investigators

  • Principal Investigator: Paul Miller, MD, Study Site

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

February 6, 2012

First Submitted That Met QC Criteria

February 9, 2012

First Posted (ESTIMATE)

February 10, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 16, 2016

Last Update Submitted That Met QC Criteria

August 8, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101.02-2011-GES-0005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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