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REMS Versus DXA for Bone Mineral Density (BMD) Evaluation

Status: Recruiting

Location: See location...

Intervention Type: Device

Study Type: Interventional

Study Phase: Not Applicable

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

Participation Requirements

Sex: Female

Minimum Age: 30

Maximum Age: 80

Healthy Volunteers: t

View:

• 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.

Locations

Other Locations

Italy

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

RECRUITING

Milan

Contact Information

Primary

Carmelo Messina, Professor

carmelomessina.md@gmail.com

0039 02 8350 1406

Time Frame

Start Date: 2019-11-19

Estimated Completion Date: 2025-12-31

Participants

Target number of participants: 296

Treatments

Other: Execution of additional diagnostic examination

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.

Related Therapeutic Areas

Osteoporosis

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