| NCT ID | NCT03621306 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Penn State University |
| Condition | Bone and Bones |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2008-06-16 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2008-06-16 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Mary Jane De Souza, PhD
PRINCIPAL INVESTIGATOR
Penn State
Frequently Asked Questions
Who can join the NCT03621306 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bone and Bones. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03621306 currently recruiting?
Yes, NCT03621306 is actively recruiting participants. Contact the research team at mjd34@psu.edu for enrollment information.
Where is the NCT03621306 trial being conducted?
This trial is being conducted at University Park, United States.
Who is sponsoring the NCT03621306 clinical trial?
NCT03621306 is sponsored by Penn State University. The principal investigator is Mary Jane De Souza, PhD at Penn State. The trial plans to enroll 400 participants.