Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06151353 |
| Other study ID # |
REMS001 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 21, 2023 |
| Est. completion date |
December 20, 2028 |
Study information
| Verified date |
November 2023 |
| Source |
OsteoscanUK Ltd |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Radiofrequency echographic multispectrometry (REMS) is a recently developed technology that
uses ultrasound to assess bone density and bone quality. It was launched in 2018 since when
OsteoscanUK Ltd has offered a clinical bone health service using a REMS scanner. REMS is an
alternative to x-ray based dual energy x-ray absorptiometry (DEXA) scans which are considered
the "Gold Standard" for clinical densitometry. REMS is unique in offering not only bone
density but also bone quality assessments in real time for both the spine and hip.
Description:
All patients who undergo REMS scans through the OsteoscanUK bone health service, are provided
with a comprehensive consent form at least two weeks ahead of the scan and are required to
complete the form before the scan is performed. The process allows consent for use of their
anonymized data for research purposes and is consistent with the General Data Protection
Regulations in the United Kingdom (UK) and Europe.
Once a REMS scan has been completed, data is extracted from the report and is entered into an
Microsoft Excel spreadsheet. Data collected includes: age, age at menopause if female,
current Fracture Risk Assessment (FRAX) score, body mass index, bone mineral density results
for the hip and spine, fragility scores for the hip and spine and any history of a fragility
fracture.
The spreadsheet is securely stored on a password protected server and the data controller is
the only person with access. Associate researchers will be provided with data from exports of
parts of the spreadsheet to allow them to carry out statistical analyses. All such data will
be managed on secure computers controlled by OsteoscanUK.
Results of the data analysis will be collected, analysed and presented as a series of papers
to be published in peer review journals. At the time of submission of such papers, the
anonymized data set would be made available to the journal editors and reviewers as required
for the purposes of publishing.
