Bone DensitometryNCT06151353
Performance of REMS Bone Densitometry in a British Population
An observational study of Bone Densitometry, run by OsteoscanUK Ltd at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Bone Densitometry
- What is being tested?
- REMS
- How many people
- 2,500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Nov 2023to 20 May 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- Adult, Older adult
Study population: Female patients in Great Britain over the age of 20 years who have clinical indications for a REMS bone health assessment.
Who may be able to join
- All women over the age of 20 years presenting for a REMS scan
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Bragborough Hall Health Centre
Daventry, Northamptonshire, NN11 7JG
About this study
Official title: Investigation of the Performance of Radiofrequency Echographic Multispectrometry (REMS) to Assess Bone Density and Bone Fragility in People Living in England, Scotland and Wales
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.
Read the detailed 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.
- Conditions
- Bone Densitometry
- Being tested
- REMS
- Keywords
- REMS, Bone densitometry, Bone mineral density, Bone fragility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REMSDiagnostic test
Bone health assessment using REMS, an ultrasound technology developed to measure bone mineral density and bone toughness without ionising radiation
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years for collection of sufficient data for meaningful analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start21 Nov 2023
- Primary completion20 Nov 2030 (estimated)
- Study completion20 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DensitometryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- OsteoscanUK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nick Birch, FRCS (Orth), Principal investigator, Director of OsteoscanUK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151353
- Sponsor's protocol ID
- REMS001
- Status last verified
- Aug 2025
- First submitted
- 21 Nov 2023
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Performance of Radiofrequency Echographic Multispectrometry (REMS) to Assess Bone Density and Bone Fragility in People Living in England, Scotland and Wales
- ClinicalTrials.gov ID
- NCT06151353
- Acronym / sponsor ID
- REMS001
- Conditions
- Bone Densitometry
- Keywords
- REMS, Bone densitometry, Bone mineral density, Bone fragility
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- OsteoscanUK LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 20 Nov 2030 (estimated)
- Study completion
- 20 May 2031 (estimated)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Female patients in Great Britain over the age of 20 years who have clinical indications for a REMS bone health assessment.
Key inclusion criteria (1 listed)
- All women over the age of 20 years presenting for a REMS scan
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REMSBone health assessment using REMS, an ultrasound technology developed to measure bone mineral density and bone toughness without ionising radiation | Diagnostic test | – |
Primary outcome
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,
Time frame: 5 years for collection of sufficient data for meaningful analysis
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nick Birch, FRCS (Orth) principal investigator
Director of OsteoscanUK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Densitometry, run by OsteoscanUK Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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, (time frame: 5 years for collection of sufficient data for meaningful analysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.