Osteoporosis DiagnosisNCT07876882
REMS vs DXA for Osteoporosis Diagnosis and Fracture Risk Prediction
An observational study of Osteoporosis Diagnosis and Bone Health, run by BoneVue Diagnostics at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Osteoporosis Diagnosis, Bone Health, Fracture
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Jun 2026to 24 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Inability to provide written informed consent
- Inability to complete an adequate REMS examination
- Declared pregnancy as collected per standard of care prior to DXA
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Rheumatology Associates of Delmarva
Easton, Maryland, 21601
Edmund MacLaughlin, +1 410-819-6545, remsus60@gmail.com
- Recruiting
Rheumatology Associates of Delmarva
Salisbury, Maryland, 21804
Edmund MacLaughlin, +1 410-860-6801, remsus60@gmail.com
About this study
Official title: Estimation of the Effectiveness of Radiofrequency Echographic Multi Spectrometry (REMS) for the Diagnosis of Osteoporosis and Fracture Risk Prediction in the United States in Comparison With Dual-Energy X-Ray Absorptiometry (DXA)
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
- Medical subject headings
- Fractures, Bone
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start24 Jun 2026
- Primary completion24 Dec 2027 (estimated)
- Study completion24 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis DiagnosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BoneVue Diagnostics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876882
- Sponsor's protocol ID
- 1409979
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of the Effectiveness of Radiofrequency Echographic Multi Spectrometry (REMS) for the Diagnosis of Osteoporosis and Fracture Risk Prediction in the United States in Comparison With Dual-Energy X-Ray Absorptiometry (DXA)
- ClinicalTrials.gov ID
- NCT07876882
- Acronym / sponsor ID
- 1409979
- Conditions
- Osteoporosis Diagnosis, Bone Health, Fracture
- Keywords
- REMS, Osteoporosis diagnosis, DXA, Bone health, Fracture
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- BoneVue DiagnosticsUniversity, hospital or other
- Study start
- 24 Jun 2026 (actual)
- Primary completion
- 24 Dec 2027 (estimated)
- Study completion
- 24 Dec 2027 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Inability to provide written informed consent
- Inability to complete an adequate REMS examination
- Declared pregnancy as collected per standard of care prior to DXA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic concordance between REMS and DXA
Time frame: Baseline
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.
Diagnostic sensitivity and specificity of REMS for osteoporosis compared with DXA
Time frame: Baseline
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.
4 secondary outcomes
Positive predictive value of REMS and DXA for fragility fractures
Time frame: Baseline through 12 months
Negative predictive value of REMS and DXA for fragility fractures
Time frame: Baseline through 12 months
Area under the ROC curve for REMS and DXA as predictors of fragility fractures
Time frame: Baseline through 12 months
Likelihood ratios for REMS versus DXA
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Osteoporosis Diagnosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis Diagnosis and Bone Health, run by BoneVue Diagnostics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic concordance between REMS and DXA (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.