Plain English Summary
Background and study aims
Ultrasound of the lumbar spine and proximal femur can be used to assess bone mass and quality. The aim of the study is to test how acceptable the ultrasound is to patients, and how easy the tests are to perform, and to compare ultrasound with the results of conventional DXA (the gold standard test for osteoporosis).
Who can participate?
Patients aged 30 to 80 attending for a DXA scan as part of routine clinical care
What does the study involve?
Having an ultrasound of the hip and lower back at the same time as participants attend for a DXA scan requested by their doctor.
What are the possible benefits and risks of participating?
Participants will help researchers understand whether the tool being tested (ultrasound) works as well as the currently used test – DXA – in identifying people with osteoporosis. This is helpful as DXA scanners are not available everywhere, and ultrasound scanners may be more affordable and accessible. There are no risks associated with this study.
Where is the study run from?
University Hospital Southampton NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
July 2017 to December 2020
Who is funding the study?
National Research Council of Italy
Who is the main contact?
Dr Elaine Dennison
emd@mrc.soton.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Elaine Dennison
ORCID ID
http://orcid.org/0000-0002-3048-4961
Contact details
Southampton University
MRC Lifecourse Epidemiology Unit
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)2380777624
emd@mrc.soton.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
CPMS 38414, IRAS 230385
Study information
Scientific title
ECHographic technologies for bone fracture risk assessments and better OSteoporosis diagnoses (ECHOS)
Acronym
ECHOS
Study hypothesis
This application seeks permission to measure ultrasound of the lumbar spine and proximal femur to assess bone mass and quality and compare it to dual-energy X-ray absorptiometry (DXA) measurements obtained at the same time and as part of usual clinical care in those participants who give consent. The aim of the study is to test how acceptable the ultrasound is to patients, and how easy the tests are to perform, and to compare results of conventional DXA (the gold standard test for osteoporosis) with ultrasound.
Ethics approval
Approved 29/06/2018, West of Scotland REC 4 (Research Ethics Clinical Research and Development, West Glasgow Ambulatory Care Hospital, Dalnair Street, Glasgow G3 8SJ, UK (Formerly Yorkhill Childrens Hospital); Tel: +44 (0)141 232 1808; Email: WoSREC4@ggc.scot.nhs.uk), REC ref: 18/WS/0102
Study design
Non-randomised; Interventional; Design type: Diagnosis, Imaging
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a participant information sheet
Condition
Osteoporosis
Intervention
All patients who are referred to the Osteoporosis centre for DXA testing at Southampton General Hospital will be considered for this study. An information sheet will be sent out with their appointment letter, detailing the study. Those patients who agree will have ultrasound scans performed at the same time as their DXA scan. This is expected to take about 5-10 minutes in total.
Intervention type
Other
Phase
Drug names
Primary outcome measure
The assessment of correlation degree and diagnostic agreement between the new ultrasound method for osteoporosis diagnosis and DXA outcome, collected at a single timepoint
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
01/07/2017
Overall trial end date
31/12/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Attending for DXA scan as part of routine clinical care
2. Both women and men
3. All ethnicities
4. Age range from 30 to 80 years
5. Body mass index (BMI) < 40 kg/m2
6. Absence of significant walking impairment
7. Medical prescription for a spinal and/or femoral DXA
8. Signed informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 5000; UK Sample Size: 1000
Participant exclusion criteria
1. Must be able to understand information sheet and give informed consent
2. Significant walking impairment
3. BMI > 40 kg/m2
Recruitment start date
18/12/2018
Recruitment end date
30/08/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospital Southampton NHS Foundation Trust
Mailpoint 18
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
University Hospital Southampton NHS Foundation Trust
Sponsor details
c/o Shauna Marshall
Mailpoint 18
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)2381208689
shauna.marshall@uhs.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Research Council of Italy
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
1. Peer-reviewed scientific journals
2. Conference presentation
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
31/12/2021
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list