REMS vs DXA for Osteoporosis Diagnosis and Fracture Risk Prediction

Part of paid clinical trials in Easton, Maryland.

Sponsor
BoneVue Diagnostics
Study ID
NCT07876882
Status
Recruiting
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Conditions

  • Bone Health
  • Fracture
  • Osteoporosis Diagnosis

Eligibility Criteria

Sex
ALL
Age
30 Years - 90 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Oct 15, 2026
Start date
Jun 24, 2026
Status verified
Oct 2026
Primary completion
Dec 24, 2027
Completion
Dec 24, 2027

Study Design

Enrollment
250 participants (estimated)

Primary Outcome Measure

Diagnostic concordance between REMS and DXA [ Time Frame: Baseline ]

Locations (2)

FacilityCityStateZIPSite coordinators
Rheumatology Associates of DelmarvaEastonMaryland21601
Edmund MacLaughlin
[email protected]
+1 410-819-6545
Rheumatology Associates of DelmarvaSalisburyMaryland21804
Edmund MacLaughlin
[email protected]
+1 410-860-6801

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Rheumatology Associates of Delmarva· Easton, MDRheumatology Associates of Delmarva· Salisbury, MD

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