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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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 2500
Est. completion date December 20, 2028
Est. primary completion date November 20, 2028
Accepts healthy volunteers
Gender Female
Age group 20 Years and older
Eligibility Inclusion Criteria: - All women over the age of 20 years presenting for a REMS scan Exclusion Criteria: - Lack of consent for the procedure and for the anonymised data to be stored and used for research; Previous bilateral total hip replacements; un controlled spasticity following a neurological injury of development of a neurodegenerative condition

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
REMS
Bone health assessment using REMS, an ultrasound technology developed to measure bone mineral density and bone toughness without ionising radiation

Locations

Country Name City State
United Kingdom Bragborough Hall Health Centre Daventry Northamptonshire

Sponsors (1)

Lead Sponsor Collaborator
OsteoscanUK Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Longitudinal assessment of the change in bone mineral density (BMD) and bone toughness (Fragility Score) and correlation with fragility fracture status, age, menopausal status and body mass index, Analysis of the change in bone health parameters measured by REMS from the start of the study until final follow-up which will be at least 24 months 5 years for collection of sufficient data for meaningful analysis
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