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Official title Bone Mineral Density Agreement Study Between EOSedge™ Versus Traditional DXA
ClinicalTrials.gov ID: NCT06659055
What this study is testing
- What it's testing
- The purpose of this research is to collect medical imaging data to allow for the comparison of bone mineral density measurements from two different types of low-dose x-ray exams, EOSedge and conventional DXA. The main question it aims to answer is: Is there agreement between the calculated T-scores between the 2 different types of x-ray exams?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older. Healthy volunteers may be eligible.
You may be able to join if
- Observational Arm: o people at clinical sites, indicated for full-spine or whole-body radiography via EOSedge 2E biplanar imaging (e.g., in the...
- treatment Arm: o Volunteers at non-clinical sites, who meet the criteria to undergo non-diagnostic imaging, as part of a research study.
- Male or female people who are at least 20 years of age at the time of imaging acquisition
- Written informed consent obtained from the potential subject and ability for the subject to comply with the requirements of the study
You likely can't join if
- people who have been administered contrast agents or radionuclides within 7 days prior to scheduled radiographic imaging (EOS and DXA)
- people who are pregnant or wanting to become pregnant during the timeframe of study participation (due to risks associated with radiographic imaging)
- people with a BMI ≥ 35 kg/m2
- people known to have severe degenerative changes or fracture deformity in the measurement area (i.e., lumbar spine L1-L4, bilateral femoral...
- people known to have implants, hardware, devices, or other foreign material in the measurement area (i.e., lumbar spine L1-L4, bilateral femoral...
- people unable to attain correct position and/or remain motionless for the measurement (e.g., people unable to stand unassisted in the EOS unit, or to...
See the full eligibility criteria
- Observational Arm: o people at clinical sites, indicated for full-spine or whole-body radiography via EOSedge 2E biplanar imaging (e.g., in the preoperative evaluation of spine and/or other orthopaedic conditions) as...
- treatment Arm: o Volunteers at non-clinical sites, who meet the criteria to undergo non-diagnostic imaging, as part of a research study.
- Male or female people who are at least 20 years of age at the time of imaging acquisition
- Written informed consent obtained from the potential subject and ability for the subject to comply with the requirements of the study
- people who have been administered contrast agents or radionuclides within 7 days prior to scheduled radiographic imaging (EOS and DXA)
- people who are pregnant or wanting to become pregnant during the timeframe of study participation (due to risks associated with radiographic imaging)
- people with a BMI ≥ 35 kg/m2
- people known to have severe degenerative changes or fracture deformity in the measurement area (i.e., lumbar spine L1-L4, bilateral femoral neck/trochanter; note that unilateral femoral evaluation is acceptable), as...
- people known to have implants, hardware, devices, or other foreign material in the measurement area (i.e., lumbar spine L1-L4, bilateral femoral neck/trochanter; note that unilateral femoral evaluation is acceptable)
- people unable to attain correct position and/or remain motionless for the measurement (e.g., people unable to stand unassisted in the EOS unit, or to lie appropriately in the DXA scanner)
- people known to have extra or missing lumbar vertebrae (i.e., more or fewer than 5 mobile lumbar segments)
- people participating in another clinical study which may compromise this study's results or compliance with this study's procedures
- people with presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Carlsbad, California, United States
- Memphis, Tennessee, United States
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Carlsbad, California, United States; Memphis, Tennessee, United States; Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.