NCT07876882Recruiting
REMS vs DXA for Osteoporosis Diagnosis and Fracture Risk Prediction
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)
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 9 Oct 2026
- Start date
- 24 Jun 2026
- Primary completion date
- 24 Dec 2027
- Lead sponsor
- BoneVue Diagnostics
- Diseases
- Osteoporosis
- NCT number
- NCT07876882
What you commit to
- Study type: Observational
- Planned participants: 250
- From 24 Jun 2026 to the primary completion date, 24 Dec 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Declared pregnancy as collected per standard of care prior to DXA
Other
- Inability to provide written informed consent
- Inability to complete an adequate REMS examination
Who the study is looking for
- 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
Age in the registry: 30 years to 90 years · Sex: All
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rheumatology Associates of Delmarva Coordinator of this site? Confirm its status | Easton | United States | Recruiting |
| Rheumatology Associates of Delmarva Coordinator of this site? Confirm its status | Salisbury | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.