Relating results from ultrasounds of the hip and spine to X-ray scans for measuring bone health
| ISRCTN | ISRCTN50126981 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50126981 |
| IRAS number | 230385 |
| Secondary identifying numbers | CPMS 38414, IRAS 230385 |
- Submission date
- 10/02/2020
- Registration date
- 02/03/2020
- Last edited
- 06/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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 2021 (updated 01/12/2020, previously: 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
Contact information
Scientific
Southampton University
MRC Lifecourse Epidemiology Unit
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
 ORCID ID |
0000-0002-3048-4961 |
|---|---|
| Phone | +44 (0)2380777624 |
| emd@mrc.soton.ac.uk |
Study information
| Study design | Non-randomised; Interventional; Design type: Diagnosis, Imaging |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | ECHographic technologies for bone fracture risk assessments and better OSteoporosis diagnoses (ECHOS) |
| Study acronym | ECHOS |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/07/2017 |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 5000; UK Sample Size: 1000 |
| Total final enrolment | 4307 |
| Key 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 |
| Key exclusion criteria | 1. Must be able to understand information sheet and give informed consent 2. Significant walking impairment 3. BMI > 40 kg/m2 |
| Date of first enrolment | 18/12/2018 |
| Date of final enrolment | 31/12/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Shauna Marshall
Mailpoint 18
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
England
United Kingdom
| Phone | +44 (0)2381208689 |
|---|---|
| shauna.marshall@uhs.nhs.uk | |
| Website | http://www.uhs.nhs.uk/home.aspx |
"ROR" |
https://ror.org/0485axj58 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | 1. Peer-reviewed scientific journals 2. Conference presentation |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1 | 01/04/2022 | 24/08/2022 | No | No |
| Results article | primary results to assess the diagnostic accuracy of Radiofrequency Echographic Multi Spectrometry (REMS) technology with respect to DXA | 24/12/2022 | 06/12/2022 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
06/12/2022: Total final enrolment was updated from the UK sample of 1000 to 4307 total trial population and a publication reference added.
24/08/2022: Uploaded protocol (not peer-reviewed) as an additional file.
08/07/2022: Total final enrolment added, the intention to publish date was changed from 31/12/2021 to 31/12/2022.
01/12/2020: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2020 to 31/12/2021.
2. The recruitment end date was changed from 31/12/2020 to 31/12/2021.
3. The plain English summary was updated to reflect these changes.
05/08/2020: The recruitment end date was changed from 30/08/2020 to 31/12/2020.
23/04/2020: Due to current public health guidance, recruitment for this study has been paused.
13/02/2020: Trial's existence confirmed by the NIHR.
