Recruiting

REMS

Sponsor:

BoneVue Diagnostics

Code:

NCT07876882

Conditions

Osteoporosis Diagnosis

Bone Health

Fracture

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07876882

Start date

Jun 24, 2026

Status verified date

Oct, 2026

Completion date

Dec 24, 2027

Anticipated

Primary completion date

Dec 24, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Diagnostic concordance between REMS and DXA [ Time Frame: Baseline ]
  • Diagnostic sensitivity and specificity of REMS for osteoporosis compared with DXA [ Time Frame: Baseline ]

Central Contacts and Locations

Locations

Rheumatology Associates of Delmarva

Recruiting

Easton, Maryland, United States, 21601

Contacts

Rheumatology Associates of Delmarva

Recruiting

Salisbury, Maryland, United States, 21804

Contacts

More Information

Sponsor

BoneVue Diagnostics

Last update posted

Oct 15, 2026

Last verified

Oct, 2026

Keywords

  • REMS
  • Osteoporosis diagnosis
  • DXA
  • Bone health
  • Fracture

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by BoneVue Diagnostics on 2026-10-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.