REMS vs DXA for Osteoporosis Diagnosis and Fracture Risk Prediction

NCT07876882 | Recruiting

• 1 other identifier: 1409979
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Osteoporosis Diagnosis; Bone Health; Fracture

Keywords

REMS; Osteoporosis diagnosis; DXA; Bone health; Fracture

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline

Secondary Outcomes (4)

• Positive predictive value of REMS and DXA for fragility fractures

  Baseline through 12 months

• Negative predictive value of REMS and DXA for fragility fractures

  Baseline through 12 months

• Area under the ROC curve for REMS and DXA as predictors of fragility fractures

  Baseline through 12 months

• Likelihood ratios for REMS versus DXA

  Baseline

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• Inability to provide written informed consent
• Inability to complete an adequate REMS examination
• Declared pregnancy as collected per standard of care prior to DXA

Sponsors & Collaborators

• BoneVue Diagnostics: lead

Study Sites (2)

Rheumatology Associates of Delmarva

Easton, Maryland, 21601, United States

RECRUITING

Rheumatology Associates of Delmarva

Salisbury, Maryland, 21804, United States

RECRUITING

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2026
• First Posted: October 15, 2026
• Study Start: June 24, 2026
• Primary Completion (Estimated): December 24, 2027
• Study Completion (Estimated): December 24, 2027
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)