Condition category
Musculoskeletal Diseases
Date applied
10/02/2020
Date assigned
02/03/2020
Last edited
02/03/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://www.uhs.nhs.uk/home.aspx

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

Publication citations

Additional files

Editorial Notes

13/02/2020: Trial's existence confirmed by the NIHR.