Clinical trial NCT06371755: Bone Evaluation by Ultrasound Radiofrequency Echographic Multi Spectrometry (REMS) vs Dual X-ray Absorptiometry (DXA)
Official title: REMS Versus DXA for Bone Mineral Density (BMD) Evaluation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoporosis Diagnosis
Keywords: REMS,
Femur
Spine
DXA
Lead sponsor: Echolight S.p.A.
Sponsor class: INDUSTRY
Collaborators: name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
First posted: 2024-04-17
Enrollment: 296
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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 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.

Eligibility 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.

Primary outcomes:
measure: 1. REMS Technology intra - and inter-operator repeatability Evaluation.
timeFrame: up to 3 months
Secondary outcomes:
measure: 1. Evaluation of the accuracy of the REMS Technology in comparison with the conventional DXA technique.
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Milano
country: Italy
facility: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
state: MI
Study officials:
affiliation: IRCCS
name: Luca M. Sconfienza, Professor
role: PRINCIPAL_INVESTIGATOR
References: