An observational study in Osteoporosis Diagnosis, Bone Health and Fracture, sponsored by BoneVue Diagnostics. Recruiting at 2 sites in United States. Open to participants aged 30 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by BoneVue Diagnostics · Observational
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.
2,272 studies on the registry are indexed under Fractures, Bone; 321 are open to participants now.
This study's planned enrollment of 250 is above the median of 100 across 677 observational studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →This is the only study on the registry with BoneVue Diagnostics as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The study population will consist of male and female U.S. subjects aged 30 to 90 years who are at risk for osteoporosis and present to Rheumatology Associates of Delmarva for evaluation of bone health or osteoporosis risk. Eligible participants must have undergone a clinically ordered DXA scan of the lumbar spine and proximal femur within the 7 days preceding the REMS examination, be able to provide written informed consent, and be able to comply with study procedures, including telephone follow-up at 6 and 12 months. The study plans to enroll approximately 250 participants with evaluable paired REMS and DXA data.
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Exclusion Criteria:
Diagnostic concordance between REMS and DXA
Agreement between REMS and DXA in classifying participants as normal, osteopenic, or osteoporotic. Concordance will be evaluated using contingency tables and Cohen's kappa coefficient.
Time frame: Baseline
Diagnostic sensitivity and specificity of REMS for osteoporosis compared with DXA
Sensitivity and specificity of Radiofrequency Echographic Multi Spectrometry (REMS) for identifying subjects with osteoporosis, using dual-energy X-ray absorptiometry (DXA) as the reference standard. Results will be reported with 95% confidence intervals.
Time frame: Baseline
Positive predictive value of REMS and DXA for fragility fractures
Positive predictive value (PPV) of REMS and DXA for the presence of prevalent or incident non-traumatic fragility fractures.
Time frame: Baseline through 12 months
Negative predictive value of REMS and DXA for fragility fractures
Negative predictive value (NPV) of REMS and DXA with respect to the occurrence of prevalent or incident fragility fractures during follow-up.
Time frame: Baseline through 12 months
Area under the ROC curve for REMS and DXA as predictors of fragility fractures
Discriminative performance of REMS and DXA for predicting fragility fractures, assessed using the area under the receiver operating characteristic curve (AUC-ROC) with 95% confidence intervals.
Time frame: Baseline through 12 months
Likelihood ratios for REMS versus DXA
Positive and negative likelihood ratios for REMS compared with DXA in the diagnostic assessment of osteoporosis. BoneVue\_CIP\_v1.0\_Final
Time frame: Baseline
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Dec 2027, 18 months after the start.
Of 207 non-industry observational studies under Fractures, Bone, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 56. This study's planned 18 months is below that.
Counting every sponsor, half of 231 studies reached it within 31 months; a quarter within 15 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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