NCT06151353

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
58mo left

Started Nov 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Nov 2023May 2031

First Submitted

Initial submission to the registry

November 21, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

November 21, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2030

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2031

Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

7 years

First QC Date

November 21, 2023

Last Update Submit

August 13, 2025

Conditions

Bone Densitometry

Keywords

REMSBone densitometryBone mineral densityBone fragility

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

REMSDIAGNOSTIC_TEST

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

Eligibility Criteria

Age20 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAll females undergoing REMS scans
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female patients in Great Britain over the age of 20 years who have clinical indications for a REMS bone health assessment.

You may qualify if:

  • All women over the age of 20 years presenting for a REMS scan

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bragborough Hall Health Centre

Daventry, Northamptonshire, NN11 7JG, United Kingdom

Location

Study Officials

  • Nick Birch, FRCS (Orth)

    Director of OsteoscanUK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2023

First Posted

November 30, 2023

Study Start

November 21, 2023

Primary Completion (Estimated)

November 20, 2030

Study Completion (Estimated)

May 20, 2031

Last Updated

August 17, 2025

Record last verified: 2025-08

Locations

GB(1)