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临床试验/NCT05216185
NCT05216185尚未招募不适用

The Assessment of Bone Health in a Clinical Setting

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust0 个研究点目标入组 5,000 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
5,000
主要终点
Use of Bone markers as a surrogate for Bone mineral density

研究概览

简要总结

The study will use data already obtained through the metabolic clinical service to improve diagnosis and management of our patients.

详细描述

Patients are referred for assessment of their bone health routinely have a bone density (BD) scan (DXA) and many also have a bone marker (BM) measurement, either NTx ( breakdown product of bone) or PINP ( formation product of bone). Patients diagnosed with osteoporosis are usually treated with a bisphosphonate drug which can halt or at least decrease the rate of bone loss.

BMs are measured pre- and post -treatment to assess adherence and effectiveness of treatment. BD measured by DXA is also used for this but in clinical practice is not recommended at intervals of less than 2 years. BMs show a much earlier clinical meaningful change - typically 2-6 months, vs BD -typically 2 years, thereby aiding swift knowledge of response or lack of response to treatment.

Although DXA remains the gold standard for initial assessment of bone health by measuring BD, BMs have an increasing role to play in patient follow up.

We propose to interrogate available data to explore whether utilizing BMs can provide monitoring information up to 5 years post-treatment thereby increasing the follow up time of the next DXA scan. This would ensure patients are not being subjected to scans using x-rays unduly and that a DXA scan is only performed when clinically needed. Additionally we want to investigate if BM levels pre-treatment reflect the response to treatment of the marker and BD, prediction of BM levels from age, fracture history, treatment, and does site of fracture affect BM and BD.

Previous work by other investigators has covered some of this ground but has not come up with definitive answers.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients on database -

排除标准

  • Not recruiting

结局指标

主要结局

Use of Bone markers as a surrogate for Bone mineral density

时间窗: 5 years

The study aims to use data already obtained through the clinical service to improve diagnosis and management of our patients. We aim to assess whether bone markers can be utilised more effectivley, thereby reducing the frequency of bone density scans a patient requires.

次要结局

未报告次要终点

研究者

发起方
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
申办方类型
Other Gov
责任方
Sponsor

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The Assessment of Bone Health in a Clinical Setting | 临床试验