Identifying factors that regulate bone health
OSTEOMICS: Identifying Regulators of Bone Homeostasis
This study is trying to find out what factors affect bone health by looking at bone samples from patients having orthopedic surgeries to help improve treatments for conditions like osteoporosis and osteoarthritis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Sponsor | Relation Therapeutics Industry-sponsored |
| Locations | 8 sites (London, Greater London and 7 other locations) |
| Trial ID | NCT05732870 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on understanding the cellular mechanisms that maintain bone homeostasis and how they relate to diseases such as osteoporosis and osteoarthritis. By recruiting patients undergoing various orthopedic surgeries, the study aims to analyze surgical bone waste to identify potential therapeutic targets for preventing bone diseases. The research will consider a wide range of factors that may contribute to bone health, including genetics, diet, and age. The goal is to develop a deeper understanding of bone disorders and improve treatment options for affected patients.
Who should consider this trial
Good fit: Ideal candidates include patients aged 18-110 undergoing orthopedic surgeries for conditions like osteoarthritis or fractures.
Not a fit: Patients who are not undergoing orthopedic surgery or those with severe comorbidities that preclude surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to novel therapeutic strategies for preventing and treating bone diseases.
How similar studies have performed: While similar studies have explored bone health, this approach of analyzing surgical bone waste for insights into bone homeostasis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with osteoarthritis undergoing total joint arthroplasty, osteotomy or arthrodesis of any joint (including hip, knee, shoulder, wrist, elbow, ankle). 2. Patient with fractured neck of femurs undergoing hemiarthroplasty or total hip arthroplasty, or other internal fixation procedure. 3. Patients undergoing acute low-velocity or fragility fracture fixation surgery. 4. 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: 1. Patients unable to provide informed consent. 2. Patients with suspected/established underlying malignancy. 3. Patients with suspected/established osteomyelitis. 4. Patients with suspected/established bloodborne disease 5. Patients who are currently a subject of a clinical trial involving an investigational medicinal product.
Where this trial is running
London, Greater London and 7 other locations
- Harley Street Specialist Hospital — London, Greater London, United Kingdom (Active_not_recruiting)
- Barts Health NHS Trust — London, United Kingdom (Recruiting)
- Chase Farm Hospital — London, United Kingdom (Recruiting)
- Fitzrovia Hospital/QASMC — London, United Kingdom (Recruiting)
- King's College Hospital — London, United Kingdom (Not_yet_recruiting)
- Luton & Dunstable University Hospital — London, United Kingdom (Active_not_recruiting)
- Royal National Orthopaedic Hospital NHS Trust — London, United Kingdom (Not_yet_recruiting)
- West Middlesex University Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Raghbir Khakha — Harley Street Specialist Hospital & Fitzrovia Hospital/QASMC
- Study coordinator: Jake Taylor-King, DPhil
- Email: jake@relationrx.com
- Phone: 447387227904
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.