OSTEOMICS: Identifying Regulators of Bone Homeostasis
OSTEOMICS
1 other identifier
observational
2,000
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2023
Longer than P75 for all trials
8 active sites
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 Start
First participant enrolled
January 12, 2023
CompletedFirst Submitted
Initial submission to the registry
January 30, 2023
CompletedFirst Posted
Study publicly available on registry
February 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2032
February 23, 2024
February 1, 2024
4.9 years
January 30, 2023
February 20, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Acquisition of bone waste
Discarded bone waste to be used for the study of RNA.
Within 4 hours of resection.
Secondary Outcomes (2)
Acquisition of 10ml of blood.
Within 4 hours of resection.
Completion of participant questionnaire
EDC entry within 1 week of surgery.
Study Arms (1)
Participant undergoing orthopaedic surgery
* Patients with osteoarthritis undergoing total joint arthroplasty, osteotomy or arthrodesis of any joint (including hip, knee, shoulder, elbow, ankle). * Patients 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.
Interventions
Inclusion criteria is purposefully broad to examine a range of discarded bone waste. Therefore, a large number of surgical interventions are relevant.
Eligibility Criteria
Participants undergoing range of orthopaedic surgeries.
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Relation Therapeuticslead
- Harley Street Specialist Hospitalcollaborator
- Fitzrovia Hospitalcollaborator
- Royal Free Hospital NHS Foundation Trustcollaborator
- Bedfordshire Hospitals NHS Foundation Trustcollaborator
- Chelsea and Westminster NHS Foundation Trustcollaborator
- Barts & The London NHS Trustcollaborator
- Royal National Orthopaedic Hospital NHS Trustcollaborator
Study Sites (8)
Harley Street Specialist Hospital
London, Greater London, W1G 8HU, United Kingdom
Barts Health NHS Trust
London, United Kingdom
Chase Farm Hospital
London, United Kingdom
Fitzrovia Hospital/QASMC
London, United Kingdom
King's College Hospital
London, United Kingdom
Luton & Dunstable University Hospital
London, United Kingdom
Royal National Orthopaedic Hospital NHS Trust
London, United Kingdom
West Middlesex University Hospital
London, United Kingdom
Biospecimen
10ml whole blood and discarded bone waste (generated from range of surgeries).
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raghbir Khakha
Harley Street Specialist Hospital & Fitzrovia Hospital/QASMC
- PRINCIPAL INVESTIGATOR
Akash Patel
Royal Free London NHS Foundation Trust
- PRINCIPAL INVESTIGATOR
Yegappan Kalairajah
Luton & Dunstable University Hospital, Bedfordshire Hospitals NHS Foundation Trust
- PRINCIPAL INVESTIGATOR
Victor Babu
Chelsea and Westminster NHS Foundation Trust
- PRINCIPAL INVESTIGATOR
Jonathan Ward
Barts & The London NHS Trust
- PRINCIPAL INVESTIGATOR
Richard Keen
Royal National Orthopaedic Hospital NHS Trust
- PRINCIPAL INVESTIGATOR
Ines Reichert
King's College Hospital NHS Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2023
First Posted
February 17, 2023
Study Start
January 12, 2023
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2032
Last Updated
February 23, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will not be released until the study is complete. Raw data files in the original format (e.g. fastq) and the accompanying anonymised phenotypic data will be uploaded to a public repository e.g. the NCBI database of Genotypes and Phenotypes (dbGaP) at https://www.ncbi.nlm.nih.gov/gap/.
- Access Criteria
- Any database selected to host genetic data must require legally-binding data access agreements with participating researchers.
It is intended that the results of the study will be reported and disseminated at international conferences and in peer-reviewed scientific journals. When the data is no longer required by Relation Therapeutics, we may grant access to raw data (without linked identifiable patient data) and the right to publish freely. There will be no reference in the study results / reports / publications to any information that would identify participants. The final dataset, which may include a small number of select fields from the EDC database, will not contain any identifiable personal data.