Estimation of the Effectiveness of Radiofrequency Echographic Multi Spectrometry (REMS) for the Diagnosis of Osteoporosis and Fracture Risk Prediction in the United States in Comparison With Dual-Energy X-Ray Absorptiometry (DXA)
BoneVue Diagnostics
Summary
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 DXA to predict fracture risk.
Eligibility
- Age range
- 30–90 years
- Sex
- All
- Healthy volunteers
- Not specified
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 * Inab…
Locations (2)
- Rheumatology Associates of DelmarvaEaston, Maryland
- Rheumatology Associates of DelmarvaSalisbury, Maryland