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REMS vs DXA for Osteoporosis Diagnosis and Fracture Risk Prediction

Recruitingn/aAges 30 Years - 90 YearsAllBoneVue Diagnostics
NCT07876882 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This prospective, observational, comparative diagnostic study will evaluate the performance of Radiofrequency Echographic Multi Spectrometry (REMS) for the diagnosis of osteoporosis and prediction of fragility fracture risk in a U.S. population, using dual-energy X-ray absorptiometry (DXA) as the reference standard. Approximately 250 male and female participants aged 30-90 years who are undergoing evaluation for bone health will be enrolled at Rheumatology Associates of Delmarva. Participants will have clinically obtained DXA results and undergo REMS assessment of the lumbar spine and proximal femur. Diagnostic performance, including sensitivity, specificity, predictive values, and concordance between REMS and DXA, will be evaluated. Participants will also be followed by telephone at 6 and 12 months to identify incident non-traumatic fragility fractures and assess the ability of REMS and

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 30-90 years at time of enrollment * Presenting for evaluation of bone health or osteoporosis risk assessment * Has undergone a clinically ordered DXA scan (lumbar spine, proximal femur) as part of routine medical care through the subject's healthcare provider within the seven days immediately preceding the REMS examination * Willing and able to provide written informed consent * Able to comply with study procedures, including telephone follow-up interviews at 6- and 12-months post-enrollment Exclusion Criteria: * Inability to provide written informed consent * Inability to complete an adequate REMS examination * Declared pregnancy as collected per standard of care prior to DXA
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What it tests

  • Not listed
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Where

2 sites
Rheumatology Associates of Delmarva
Easton, United States
Rheumatology Associates of Delmarva
Salisbury, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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