REMS testing for osteoporosis diagnosis and fracture risk in adults compared with DXA

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study compares Radiofrequency Echographic Multi Spectrometry (REMS) to dual-energy X-ray absorptiometry (DXA) for diagnosing osteoporosis and predicting fragility fractures. Enrolling about 250 men and women aged 30–90 undergoing bone-health evaluation, all participants will have a prior DXA and will receive a REMS assessment of the lumbar spine and proximal femur. Diagnostic performance will be analyzed in terms of sensitivity, specificity, predictive values, and concordance with DXA. Participants will be followed by telephone at 6 and 12 months to identify incident non-traumatic fragility fractures and to assess how well REMS and DXA predict fracture risk.

Why it matters

Who can join: the full rules

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
* Inability to complete an adequate REMS examination
* Declared pregnancy as collected per standard of care prior to DXA

Where it's running

• Rheumatology Associates of Delmarva
  Easton, Maryland, United States Recruiting
• Rheumatology Associates of Delmarva
  Salisbury, Maryland, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.