Recruiting

Observational Study

Sponsor:

Penn State University

Code:

NCT03621306

Conditions

Bone and Bones

Body Composition

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

DXA and pQCT precision testing

Study Details

Brief summary:

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.

Conditions

Bone and Bones

Body Composition

Study ID

NCT03621306

Start date

Jun 16, 2008

Status verified date

Jul, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

Healthy adults of two age groups, 1) aged 18-40 or 2) aged >40yr.

Exclusion Criteria:

1. for females, being pregnant
2. Having had X-ray procedures using contrast material in the previous 3 days
3. Having medical devices that interfere with scan accuracy
4. Wearing external metal objects that cannot be removed
5. Having internal metal objects
6. Body mass of > 450 lbs.
7. Having ostomies

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Men and women aged 18+

Men and women over the age of 18

Interventions

DXA and pQCT precision testing

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..

Primary outcome measure

  • Precision of iDXA BMD [ Time Frame: One month ]
  • Precision of Hologic Horizon W DXA BMD [ Time Frame: One month ]
  • Precision of iDXA Body Composition [ Time Frame: One month ]
  • Precision of Hologic Horizon W DXA Body Composition [ Time Frame: One month ]
  • Precision of the Stratec XCT 3000 pQCT [ Time Frame: One month ]

Central Contacts and Locations

Central contacts

Mary Jane De Souza, PhD

814-863-0045mjd34@psu.edu

Nicole Strock, MS

814-863-4488nca11@psu.edu

Locations

Women's Health and Exercise Laboratories, The Pennsylvania State University

Recruiting

University Park, Pennsylvania, United States, 16802

Contacts

Mary Jane De Souza, PhD

814-863-0045mjd34@psu.edu

Principal Investigator:

Mary Jane De Souza, Ph.D.

More Information

Sponsor

Penn State University

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Penn State University on 2026-07-06.