Bone Evaluation by Ultrasound Radiofrequency Echographic Multi Spectrometry (REMS) vs Dual X-ray Absorptiometry (DXA)

NCT06371755 | Recruiting

• 1 other identifier: ULTRADXA
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoporosis Diagnosis

Keywords

REMS,; Femur; Spine; DXA

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 3 months

Secondary Outcomes (1)

• 1. Evaluation of the accuracy of the REMS Technology in comparison with the conventional DXA technique.

  through study completion, an average of 1 year

Study Arms (1)

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.

Device: Ultrasound examination with REMS technology

Interventions

Ultrasound examination with REMS technology DEVICE

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.

Execution of additional diagnostic examination

Eligibility Criteria

• Age: 30 Years - 80 Years
• Gender Eligibility Details: Only Women were included in the study since female population undergoes densitometric examinations more frequently that the male one.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Male sex,
• severe walking difficulties,
• age below 30 years or over 80 years,
• severe obesity (BMI \> 40 kg/m2),
• declared pregnancy.

Sponsors & Collaborators

• Paola Pisani: lead
• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: collaborator

Study Sites (1)

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Milan, MI, 20157, Italy

RECRUITING

Study Officials

• Luca M. Sconfienza, Professor

  IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmelo Messina, Professor

CONTACT

0039 02 8350 1406; carmelomessina.md@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Director

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: April 17, 2024
• Study Start: November 19, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)