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临床试验/NCT06151353
NCT06151353Enrolling By Invitation不适用

Investigation of the Performance of Radiofrequency Echographic Multispectrometry (REMS) to Assess Bone Density and Bone Fragility in People Living in England, Scotland and Wales

OsteoscanUK Ltd1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2023年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
2,500
试验地点
1
主要终点
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,

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

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,

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
OsteoscanUK Ltd
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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