Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371755
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-03-08
Brief Title:
Bone Evaluation by Ultrasound Radiofrequency Echographic Multi Spectrometry REMS vs Dual X-ray Absorptiometry DXA
Sponsor:
Paola Pisani
Organization:
Echolight SpA
Study Overview
Official Title:
REMS Versus DXA for Bone Mineral Density BMD Evaluation
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 studyIRCCS Orthopedic institute Galeazzi - SantAmbrogio The clinical study will evaluate the intra- and inter-operator repeatability of the REMSRadiofrequency 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
Clinical Center involved in the studyIRCCS Orthopedic institute Galeazzi - SantAmbrogio The clinical study will evaluate the intra- and inter-operator repeatability of the REMSRadiofrequency 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 -25 and as non-osteoporotic if lumbar T-score -25 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 -25 T-score -10 or healthy if T-score -10
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
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 -25 and as non-osteoporotic if lumbar T-score -25 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 -25 T-score -10 or healthy if T-score -10
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None