Osteoporosis DiagnosisNCT06371755
Bone Evaluation by Ultrasound Radiofrequency Echographic Multi Spectrometry (REMS) vs Dual X-ray Absorptiometry (DXA)
A study testing Ultrasound examination with REMS technology in people with Osteoporosis Diagnosis, run by Paola Pisani at 1 site in Italy.
Trial summary
Bone Density Evaluation by means of the Ultrasound Technology Named Radiofrequency Echographic Multi Spectrometry (REMS) in Comparison With DXA Technique. Clinical Center involved in the study:IRCCS Orthopedic institute Galeazzi - Sant'Ambrogio The clinical study will evaluate the intra- and inter-operator… Read more about this study
- Who is it for?
- Ages 30 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis Diagnosis
- What is being tested?
- Ultrasound examination with REMS technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteItaly
- Study dates
- 19 Nov 2019to 31 Dec 2025
- Phase
- Interventional
- 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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients scheduled for lumbar and/or femoral DXA examination,
- female sex,
- age range 30-80 years (for repeatability study), age range 50-70 years (for accuracy study),
- absence of severe obesity (BMI < 40 kg/m2),
- absence of severe walking difficulties,
- cognitive underwriting of informed consent.
Who cannot join
- Male sex,
- severe walking difficulties,
- age below 30 years or over 80 years,
- severe obesity (BMI > 40 kg/m2),
- declared pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Milan, MI, 20157
Carmelo Messina, Professor, 0039 02 8350 1406, carmelomessina.md@gmail.com
About this study
Official title: REMS Versus DXA for Bone Mineral Density (BMD) Evaluation
Bone Density Evaluation by means of the Ultrasound Technology Named Radiofrequency Echographic Multi Spectrometry (REMS) in Comparison With DXA Technique.
Clinical Center involved in the study:IRCCS Orthopedic institute Galeazzi - Sant'Ambrogio The clinical study will evaluate the intra- and inter-operator repeatability of the REMS,(Radiofrequency Echographic Multi Spectrometry) ultrasound diagnostic technology implemented in the EchoStation device (Echolight Spa, Lecce) and the diagnostic accuracy in comparison with DXA (used as standard reference).
Read the detailed description
The study protocol was approved by the Ethics Review Boards of the Galeazzi Hospital in Milan (Comitato Etico San Raffaele, Milano, Italy). According to the protocol, only women will be enrolled because they are the vast majority of subjects usually tested for BMD using DXA. Women who voluntarily entered the study, will provide written informed consent and authorization for anonymized data publication.
To determine the short-term intra-operator precision and inter-operator repeatability of radiofrequency echographic multi-spectrometry (REMS) at the lumbar spine (LS) and proximal femur (FEM). All patients will undergo an ultrasound scan of the LS and FEM. Both precision and repeatability, expressed as root-mean-square coefficient of variation (RMS-CV) and least significant change (LSC) will be evaluated using data from two consecutive REMS acquisitions by the same operator or two different operators, respectively. The precision will be also assessed in the cohort stratified according to BMI classification.
To evaluate the comparison between REMS and DXA diagnostic results, spinal DXA reports were processed separately from femoral ones. According to spinal DXA reports, each patient was classified as osteoporotic^ if lumbar T-score≤ -2.5 and as non-osteoporotic if lumbar T-score > -2.5. An independent classification employing the same threshold was adopted on the basis of femoral neck T-score values obtained from femoral DXA reports. In both cases the non-osteoporotic patients were further classified as osteopenic if -2.5 < T-score < -1.0 or healthy^ if T-score≥ -1.0.
The whole classification process was independently repeated on the basis of the corresponding lumbar and femoral neck T-score values obtained from REMS scans.
Diagnostic accuracy of the REMS approach was then assessed by assuming DXA outputs as the standard reference. The diagnostic concordance between the two methods was assessed, by calculating the percentage of patients being classified in the same diagnostic category (osteoporotic, osteopenic, or healthy) by both DXA and REMS together with the degree of correlation between DXA and REMS T-score values.
- Conditions
- Osteoporosis Diagnosis
- Being tested
- Ultrasound examination with REMS technology
- Keywords
- REMS,, Femur, Spine, DXA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound examination with REMS technologyDevice
The proposed study is defined as interventional because it introduces an ultrasound examination in the standard clinical routine. The diagnostic approach does not vary during the study and the prescription of any therapeutic treatment is performed on the basis of the conventional DXA diagnosis. This ultrasound examination does not involve additional risks for the patient with the benefit of not using ionizing radiation; it lasts only few minutes and can be performed without moving the patient from the same bed on which he is already positioned for DXA examination.
| Study group | Role | What they receive |
|---|---|---|
| Execution of additional diagnostic examination | Other | The proposed study is defined as interventional because it introduces an ultrasound examination in the standard clinical routine. The diagnostic approach does not vary during the study and the prescription of any therapeutic treatment is performed on the basis of the conventional DXA diagnosis. This ultrasound examination does not involve additional risks for the patient with the benefit of not using ionizing radiation; it lasts only few minutes and can be performed without moving the patient from the same bed on which he is already positioned for DXA examination. Receives: Device: Ultrasound examination with REMS technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. REMS Technology intra - and inter-operator repeatability Evaluation.
The Root Mean Square - Coefficient of Variation (CV-RMS) parameter has been measured in order to calculate REMS intra- and inter-operator repeatability.
Measured: up to 3 months
Secondary outcomes (1)
1. Evaluation of the accuracy of the REMS Technology in comparison with the conventional DXA technique.
Evaluation of the diagnostic agreement between the two used diagnostic techniques.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start19 Nov 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paola Pisani
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Responsible party
- Sponsor-investigator, Paola Pisani, Echolight S.p.A.
- Investigators
- Luca M. Sconfienza, Professor, Principal investigator, IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371755
- Sponsor's protocol ID
- ULTRADXA
- Status last verified
- Aug 2025
- First submitted
- 8 Mar 2024
- Last updated
- 5 Sep 2025
- 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 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REMS Versus DXA for Bone Mineral Density (BMD) Evaluation
- ClinicalTrials.gov ID
- NCT06371755
- Acronym / sponsor ID
- ULTRADXA
- Conditions
- Osteoporosis Diagnosis
- Keywords
- REMS,, Femur, Spine, DXA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- Paola PisaniIndustry (pharma, biotech, devices)
- Collaborators
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Apr 2024 (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.
Bone Density Evaluation by means of the Ultrasound Technology Named Radiofrequency Echographic Multi Spectrometry (REMS) in Comparison With DXA Technique.
Clinical Center involved in the study:IRCCS Orthopedic institute Galeazzi - Sant'Ambrogio The clinical study will evaluate the intra- and inter-operator repeatability of the REMS,(Radiofrequency Echographic Multi Spectrometry) ultrasound diagnostic technology implemented in the EchoStation device (Echolight Spa, Lecce) and the diagnostic accuracy in comparison with DXA (used as standard reference).
Detailed description
The study protocol was approved by the Ethics Review Boards of the Galeazzi Hospital in Milan (Comitato Etico San Raffaele, Milano, Italy). According to the protocol, only women will be enrolled because they are the vast majority of subjects usually tested for BMD using DXA. Women who voluntarily entered the study, will provide written informed consent and authorization for anonymized data publication.
To determine the short-term intra-operator precision and inter-operator repeatability of radiofrequency echographic multi-spectrometry (REMS) at the lumbar spine (LS) and proximal femur (FEM). All patients will undergo an ultrasound scan of the LS and FEM. Both precision and repeatability, expressed as root-mean-square coefficient of variation (RMS-CV) and least significant change (LSC) will be evaluated using data from two consecutive REMS acquisitions by the same operator or two different operators, respectively. The precision will be also assessed in the cohort stratified according to BMI classification.
To evaluate the comparison between REMS and DXA diagnostic results, spinal DXA reports were processed separately from femoral ones. According to spinal DXA reports, each patient was classified as osteoporotic^ if lumbar T-score≤ -2.5 and as non-osteoporotic if lumbar T-score > -2.5. An independent classification employing the same threshold was adopted on the basis of femoral neck T-score values obtained from femoral DXA reports. In both cases the non-osteoporotic patients were further classified as osteopenic if -2.5 < T-score < -1.0 or healthy^ if T-score≥ -1.0.
The whole classification process was independently repeated on the basis of the corresponding lumbar and femoral neck T-score values obtained from REMS scans.
Diagnostic accuracy of the REMS approach was then assessed by assuming DXA outputs as the standard reference. The diagnostic concordance between the two methods was assessed, by calculating the percentage of patients being classified in the same diagnostic category (osteoporotic, osteopenic, or healthy) by both DXA and REMS together with the degree of correlation between DXA and REMS T-score values.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Execution of additional diagnostic examination | Other | Device: Ultrasound examination with REMS technologyThe proposed study is defined as interventional because it introduces an ultrasound examination in the standard clinical routine. The diagnostic approach does not vary during the study and the prescription of any therapeutic treatment is performed on the basis of the conventional DXA diagnosis. This ultrasound examination does not involve additional risks for the patient with the benefit of not using ionizing radiation; it lasts only few minutes and can be performed without moving the patient from the same bed on which he is already positioned for DXA examination. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients scheduled for lumbar and/or femoral DXA examination,
- female sex,
- age range 30-80 years (for repeatability study), age range 50-70 years (for accuracy study),
- absence of severe obesity (BMI < 40 kg/m2),
- absence of severe walking difficulties,
Key exclusion criteria (5 listed)
- Male sex,
- severe walking difficulties,
- age below 30 years or over 80 years,
- severe obesity (BMI > 40 kg/m2),
- declared pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound examination with REMS technologyThe proposed study is defined as interventional because it introduces an ultrasound examination in the standard clinical routine. The diagnostic approach does not vary during the study and the prescription of any therapeutic treatment is performed on the basis of the conventional DXA diagnosis. This ultrasound examination does not involve additional risks for the patient with the benefit of not using ionizing radiation; it lasts only few minutes and can be performed without moving the patient from the same bed on which he is already positioned for DXA examination. | Device | Execution of additional diagnostic examination |
Primary outcome
1. REMS Technology intra - and inter-operator repeatability Evaluation.
Time frame: up to 3 months
The Root Mean Square - Coefficient of Variation (CV-RMS) parameter has been measured in order to calculate REMS intra- and inter-operator repeatability.
1 secondary outcome
1. Evaluation of the accuracy of the REMS Technology in comparison with the conventional DXA technique.
Time frame: through study completion, an average of 1 year
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 5 Sep 2025.
- 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.
Luca M. Sconfienza, Professor principal investigator
IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound examination with REMS technology in people with Osteoporosis Diagnosis, run by Paola Pisani at 1 site in Italy.
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 6 inclusion and 5 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 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Contact Carmelo Messina, Professor (0039 02 8350 1406, carmelomessina.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. REMS Technology intra - and inter-operator repeatability Evaluation. (time frame: up to 3 months). 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 5 Sep 2025.