Health TrialsbyHealthPanel

DXA Study of Precision and Reliability

ConditionsBone and BonesBody Composition
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPenn State University

About this trial

The purpose of the study is to assess precision of the GE Lunar iDXA, Hologic Horizon W DXA scanner, and the Stratec peripheral quantitative computed tomography (pQCT) scanner.

Aim 1: To assess standard deviation (SD) and coefficient of variation (CV) of testing bone mineral, bone geometry, and soft tissues in inanimate objects and adults. Tests on adults will be structured to assess:

1. Within- and between-day variability of testing 2. Within- and between-technician variability of testing 3. Variability due to positioning and post-scan processing 4. Variability due to different DXA scanning equipment

Aim 2: To assess the least significant change (LSC) for testing bone mineral and soft tissues in adults.

Aim 3: To assess strengths and limitations of DXA and pQCT testing, including sensitivity to movement, rate of re-rescanning, etc. which are crucial components for demonstrating feasibility in grant applications.

Aim 4: To construct a database of DXA and pQCT test results and quality control procedures, showing our laboratory's quality control level.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

for females, being pregnant

Having had X-ray procedures using contrast material in the previous 3 days

Having medical devices that interfere with scan accuracy

Wearing external metal objects that cannot be removed

Trial population

Volunteers will include men and women of all ages. Women must not be pregnant.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • DXA and pQCT precision testing

    Device

    The participants are only being observed; there is no intervention other than DXA and pQCT testing for the purposes of looking at instrument/technician precision..

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: Men and women aged 18+1 intervention

Trial outcomes

Primary outcomes

1

Precision of iDXA BMD

Standard Deviation and coefficient of variation for BMD measurements obtained on the GE Lunar iDXA

Time frame
One month
2

Precision of Hologic Horizon W DXA BMD

Standard Deviation and coefficient of variation for BMD measurements obtained on the Hologic Horizon W

Time frame
One month
3

Precision of iDXA Body Composition

Standard Deviation and coefficient of variation for body composition measurements obtained on the GE Lunar iDXA

Time frame
One month
4

Precision of Hologic Horizon W DXA Body Composition

Standard Deviation and coefficient of variation for body composition measurements obtained on the Hologic Horizon W

Time frame
One month

Secondary outcomes

1

LSC for the iDXA BMD

Least significant change for BMD using the GE Lunar iDXA

Time frame
One month
2

LSC for the Hologic Horizon W BMD

Least significant change for BMD using the Hologic Horizon W DXA

Time frame
One month
3

LSC for the iDXA body composition

Least significant change for body composition using the GE Lunar iDXA

Time frame
One month
4

LSC for the Hologic Horizon W body composition

Least significant change for body composition using the Hologic Horizon W DXA

Time frame
One month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Penn State University

Lead sponsor

Source ClinicalTrials.gov
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