Actively Recruiting
Bone Mineral Density Assessment Using Dual-energy Stereoradiography: Agreement Between BMD T-scores From EOSedge Versus Traditional DXA - BMD Agreement Study
Led by Alphatec Spine, Inc. · Updated on 2025-02-14
214
Participants Needed
4
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a study to compare bone mineral density (BMD) measurements from two types of low-dose X-ray exams: EOSedge and traditional DXA. The study aims to determine if the T-scores calculated from these two imaging methods agree. This multi-center, prospective, controlled, cross-sectional agreement study involves participants who either need EOSedge imaging as part of their routine care or volunteers undergoing non-diagnostic imaging. Participants will undergo both EOSedge and DXA scans. EOSedge exams will be performed as usual for evaluating spinal or orthopedic conditions, while DXA exams will be done as study-prescribed or standard care, ideally on the same day as EOSedge but up to 60 days apart. Healthy volunteers will receive both imaging tests, and those receiving EOSedge imaging as standard care will also receive an additional DXA scan. During the study, participants will have demographic and diagnostic information collected via case report forms and complete a questionnaire before the DXA scan. The researchers will assess the agreement of T-scores between the two imaging methods over a period of up to 60 days. The total duration of participation covers consent through completion of image acquisition. Safety is monitored by excluding participants with conditions affecting imaging quality or safety risks.
CONDITIONS
Brief Title
Bone Mineral Density Agreement Study Between EOSedge™ Versus Traditional DXA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects indicated for full-spine or whole-body EOSedge imaging as part of routine medical care
- Volunteers eligible for non-diagnostic imaging in a research setting
- Male or female subjects aged 20 years or older at imaging
- Ability to provide written informed consent and comply with study requirements
You will not qualify if you...
- Use of contrast agents or radionuclides within 7 days prior to imaging
- Pregnancy or plans to become pregnant during study participation
- Body mass index (BMI) of 35 kg/m2 or higher
- Severe degenerative changes or fracture deformities in lumbar spine or femoral neck areas
- Presence of implants, hardware, or foreign material in measurement areas
- Inability to hold correct position or remain still during imaging
- Extra or missing lumbar vertebrae
- Participation in another clinical study that may affect this study
- Any condition that may compromise safety or data quality as judged by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) to assess eligibility and obtain informed consent
Duration - Up to 60 days
Participants undergo EOSedge and DXA imaging to assess bone mineral density (BMD).
1 to 2 imaging visits depending on scheduling between EOSedge and DXA scans
Trial Site Locations
Total: 4 locations
1
Honor Health
Phoenix, Arizona, United States, 85027
Actively Recruiting
2
ATEC Carlsbad
Carlsbad, California, United States, 92008
Active, Not Recruiting
3
ATEC Mephis
Memphis, Tennessee, United States, 38118
Active, Not Recruiting
4
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
S
Sr. Manager, Clinical Studies
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here