Bone Evaluation by Ultrasound Radiofrequency Echographic Multi Spectrometry (REMS) vs Dual X-ray Absorptiometry (DXA)
REMS Versus DXA for Bone Mineral Density (BMD) Evaluation
Paola Pisani
296 participants
Nov 19, 2019
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria6
- 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 Criteria5
- Male sex,
- severe walking difficulties,
- age below 30 years or over 80 years,
- severe obesity (BMI > 40 kg/m2),
- declared pregnancy.
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Interventions
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)
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NCT06371755