Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05732870

OSTEOMICS: Identifying Regulators of Bone Homeostasis

Diseases of bone associated with ageing, including osteoporosis (OP) and osteoarthritis (OA), reduce bone mass, bone strength and joint integrity. Current non-surgical approaches are limited to pharmaceutical agents that are not disease modifying and have poor patient tolerability due to side effect profiles. Developing a fundamental understanding of cellular bone homeostasis, including how key cell types affect tissue health, and offering novel therapeutic targets for prevention of bone disease is therefore essential. This is the focus of OSTEOMICS.

A number of factors have been linked to increased risk of bone disease, including genetic predisposition, diet, smoking, ageing, autoimmune disorders and endocrine disorders. In our study, we will recruit patients undergoing elective and non-elective orthopaedic surgery and obtain surgical bone waste for analysis. This will capture a cohort of patients with bone disorders like OP and OA, in addition to patients without overt clinical bone disease. We will study the relationship between the molecular biology of bone cells, bone structure, genetics (DNA) and environmental factors with the aim of identifying and validating novel therapeutic targets.

We will leverage modern single cell technologies to understand the diversity of cell types found in bone. These technologies have now led to the characterisation of virtually every tissue in the body, however bone and bone-adjacent tissues are massively underrepresented due to the anatomical location and underlying technical challenges. Early protocols to demineralise bone and perform single cell profiling have now been developed. We will systematically scale up these efforts to observe how genetic variation at the population level leads to alterations in bone structure and quality.

Over the next 10 years, we will generate data to comprehensively characterise bone across health and disease, use machine learning to drive analysis, and experimentally validate hypotheses - which will ultimately contribute to developing the next generation of therapeutic agents.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Harley Street Specialist Hospital, London, Greater London, United Kingdom

Loading trial locations.

Who can participate

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

Inclusion criteria

  • Patients with osteoarthritis undergoing total joint arthroplasty, osteotomy or arthrodesis of any joint (including hip, knee, shoulder, wrist, elbow, ankle).
  • Patient with fractured neck of femurs undergoing hemiarthroplasty or total hip arthroplasty, or other internal fixation procedure.
  • Patients undergoing acute low-velocity or fragility fracture fixation surgery.
  • Patients aged between 18-110 years old with capacity to consent.

Since deteriorating bone health including diseases like osteoporosis are primarily conditions of older age there is no practical upper age-limit. However, study involvement is limited by suitability for surgery which encompasses multiple factors considered on an individual case basis including age, frailty, comorbidities, baseline mobility, renal function and ability to consent (for instance due to dementia or delirium).

We note that our inclusion criteria is purposefully broad as we aim to deduce trends across a wide range of conditions and backgrounds.

Exclusion criteria

  • Patients unable to provide informed consent.
  • Patients with suspected/established underlying malignancy.
  • Patients with suspected/established osteomyelitis.
  • Patients with suspected/established bloodborne disease
  • Patients who are currently a subject of a clinical trial involving an investigational medicinal product.

Treatment and study plan

Relevant orthopaedic surgery

Procedure

Inclusion criteria

is purposefully broad to examine a range of discarded bone waste. Therefore, a large number of surgical interventions are relevant.

Primary outcomes

  1. Acquisition of bone waste

    Time frame: Within 4 hours of resection.

    Discarded bone waste to be used for the study of RNA.

Secondary outcomes

  1. Acquisition of 10ml of blood.

    Time frame: Within 4 hours of resection.

    Discarded blood to be used for genetic sequencing, and/or other downstream omics/assays

  2. Completion of participant questionnaire

    Time frame: EDC entry within 1 week of surgery.

    Patient metadata to be used to understand cohort and identify confounding factors.

Study contacts

Contact information is provided by the study sponsor or research team.

Jake Taylor-King, DPhil

CONTACT

[email protected]

447387227904

Susan O'Connor

CONTACT

[email protected]

07513017280

Sponsors and collaborators

Lead sponsor

Relation Therapeutics

Industry

Collaborators

  • Barts & The London NHS Trust
  • Bedfordshire Hospitals NHS Foundation Trust
  • Chelsea and Westminster NHS Foundation Trust
  • Fitzrovia Hospital
  • Harley Street Specialist Hospital
  • Royal Free Hospital NHS Foundation Trust
  • Royal National Orthopaedic Hospital NHS Trust

Registry information

Acronym: OSTEOMICS

Important dates

Study start
2023
Primary completion
2027
Study completion
2032
First posted
Feb 17, 2023
Registry last updated
Feb 23, 2024

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.

Published trials that share one or more normalized conditions with this study.