NCT03621306

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
28mo left

Started Jun 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jun 2008Aug 2028

Study Start

First participant enrolled

June 16, 2008

Completed
10.1 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

20.2 years

First QC Date

August 3, 2018

Last Update Submit

May 7, 2025

Conditions

Bone and BonesBody Composition

Outcome Measures

Primary Outcomes (5)

  • Precision of iDXA BMD

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

    One month

  • Precision of Hologic Horizon W DXA BMD

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

    One month

  • Precision of iDXA Body Composition

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

    One month

  • Precision of Hologic Horizon W DXA Body Composition

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

    One month

  • Precision of the Stratec XCT 3000 pQCT

    Standard deviation and coefficient of variation for bone density, geometry, and estimated bone strength for the Stratec XCT 3000 pQCT

    One month

Secondary Outcomes (5)

  • LSC for the iDXA BMD

    One month

  • LSC for the Hologic Horizon W BMD

    One month

  • LSC for the iDXA body composition

    One month

  • LSC for the Hologic Horizon W body composition

    One month

  • LSC for the Stratec XCT 3000

    One month

Study Arms (1)

Men and women aged 18+

Men and women over the age of 18

Device: DXA and pQCT precision testing

Interventions

DXA and pQCT precision testingDEVICE

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..

Men and women aged 18+

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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
  • Having internal metal objects
  • Body mass of \> 450 lbs.
  • Having ostomies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

University Park, Pennsylvania, 16802, United States

RECRUITING

MeSH Terms

Interventions

Absorptiometry, Photon

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Mary Jane De Souza, PhD

    Penn State

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Jane De Souza, PhD

CONTACT

814-863-0045mjd34@psu.edu

Nicole Strock, MS

CONTACT

814-863-4488nca11@psu.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Kinesiology

Study Record Dates

First Submitted

August 3, 2018

First Posted

August 8, 2018

Study Start

June 16, 2008

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

May 13, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)