Evaluating bone density using ultrasound technology compared to DXA
REMS Versus DXA for Bone Mineral Density (BMD) Evaluation
NA · Echolight S.p.A. · NCT06371755
This study is testing a new ultrasound method to see if it can accurately measure bone density in women aged 30-80 compared to the standard DXA scan.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 296 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | Female |
| Sponsor | Echolight S.p.A. (industry) |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT06371755 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Radiofrequency Echographic Multi Spectrometry (REMS) ultrasound technology for assessing bone density in comparison to the standard Dual X-ray Absorptiometry (DXA). It focuses on measuring the intra- and inter-operator repeatability of REMS at the lumbar spine and proximal femur. The study will enroll women aged 30-80 years who are scheduled for DXA examinations and will analyze the diagnostic accuracy of REMS against DXA results. Participants will undergo ultrasound scans, and the results will be compared to DXA reports to classify patients as osteoporotic or non-osteoporotic.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 30-80 who are scheduled for lumbar and/or femoral DXA examinations.
Not a fit: Patients who are male, have severe walking difficulties, or are outside the age range of 30-80 years will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive and more accessible method for diagnosing osteoporosis.
How similar studies have performed: Other studies have shown promising results with ultrasound technologies for bone density evaluation, but this specific approach using REMS is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Male sex, * severe walking difficulties, * age below 30 years or over 80 years, * severe obesity (BMI \> 40 kg/m2), * declared pregnancy.
Where this trial is running
Milan, MI
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio — Milan, MI, Italy (RECRUITING)
Study contacts
- Principal investigator: Luca M. Sconfienza, Professor — IRCCS
- Study coordinator: Carmelo Messina, Professor
- Email: carmelomessina.md@gmail.com
- Phone: 0039 02 8350 1406
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteoporosis Diagnosis, REMS,, Femur, Spine, DXA