RECRUITINGINTERVENTIONAL

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

REMS Versus DXA for Bone Mineral Density (BMD) Evaluation

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. Who Should NOT Join This Trial: - Male sex, - severe walking difficulties, - age below 30 years or over 80 years, - severe obesity (BMI \> 40 kg/m2), - declared pregnancy. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DEVICE

Ultrasound examination with REMS technology

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.

Locations (1)

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

Milan, MI, Italy