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NCT Number: NCT05216185

The Assessment of Bone Health in a Clinical Setting

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

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

The study is expected to take 5 years and will not involve additional investigations compared to standard care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients on database -

Exclusion criteria

Not recruiting

-

Treatment and study plan

Primary outcomes

  1. Use of Bone markers as a surrogate for Bone mineral density

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Other Gov

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jan 31, 2022
Registry last updated
May 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.