OsteoporosisOSTEOMICSNCT05732870
OSTEOMICS: Identifying Regulators of Bone Homeostasis
An observational study of Osteoporosis and Osteoarthritis, run by Relation Therapeutics at 8 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Osteoporosis, Osteoarthritis, Bone Diseases
- What is being tested?
- Relevant orthopaedic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- 12 Jan 2023to Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- Adult, Older adult
Study population: Participants undergoing range of orthopaedic surgeries.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United Kingdom8 sites, 6 recruiting
- Active, not recruiting
Harley Street Specialist Hospital
London, Greater London, W1G 8HU
- Recruiting
Barts Health NHS Trust
London
Catherine Hilton, catherine.hilton1@nhs.net
Jonathan Ward
- Recruiting
Chase Farm Hospital
London
Olaoluwa Olaosebikan, olaoluwa.olaosebikan@nhs.net
Akash Patel
- Recruiting
Fitzrovia Hospital/QASMC
London
Nazish Daudi, nazish.daudi@qasmc.com
Brian Leaker, brian.leaker@qasmc.com
- Not yet recruiting
King's College Hospital
London
Kerim Gokturk, agokturk@nhs.net
Ines Reichert
- Active, not recruiting
Luton & Dunstable University Hospital
London
- Not yet recruiting
Royal National Orthopaedic Hospital NHS Trust
London
Richard Keen
Richard Keen
- Recruiting
West Middlesex University Hospital
London
Amrinder Sayan, amrinder.sayan@nhs.net
Victor Babu
About this study
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.
Read more
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.
- Conditions
- Osteoporosis, Osteoarthritis, Bone Diseases, Bone Fracture, Bone Marrow Disease
- Being tested
- Relevant orthopaedic surgery
- Medical subject headings
- Osteoporosis, Osteoarthritis, Bone Diseases, Fractures, Bone, Bone Marrow Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relevant orthopaedic surgeryProcedure or surgery
Inclusion criteria is purposefully broad to examine a range of discarded bone waste. Therefore, a large number of surgical interventions are relevant.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Relevant orthopaedic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acquisition of bone waste
Discarded bone waste to be used for the study of RNA.
Measured: Within 4 hours of resection.
Secondary outcomes (2)
Acquisition of 10ml of blood.
Discarded blood to be used for genetic sequencing, and/or other downstream omics/assays
Measured: Within 4 hours of resection.
Completion of participant questionnaire
Patient metadata to be used to understand cohort and identify confounding factors.
Measured: EDC entry within 1 week of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start12 Jan 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Relation Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Harley Street Specialist Hospital, Fitzrovia Hospital, Royal Free Hospital NHS Foundation Trust, Bedfordshire Hospitals NHS Foundation Trust, Chelsea and Westminster NHS Foundation Trust, Barts & The London NHS Trust, Royal National Orthopaedic Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- Raghbir Khakha, Principal investigator, Harley Street Specialist Hospital & Fitzrovia Hospital/QASMCAkash Patel, Principal investigator, Royal Free London NHS Foundation TrustYegappan Kalairajah, Principal investigator, Luton & Dunstable University Hospital, Bedfordshire Hospitals NHS Foundation TrustVictor Babu, Principal investigator, Chelsea and Westminster NHS Foundation TrustJonathan Ward, Principal investigator, Barts & The London NHS TrustRichard Keen, Principal investigator, Royal National Orthopaedic Hospital NHS TrustInes Reichert, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732870
- Sponsor's protocol ID
- RRx-Profiling-001
- Acronym
- OSTEOMICS
- Status last verified
- Aug 2026
- First submitted
- 30 Jan 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OSTEOMICS: Identifying Regulators of Bone Homeostasis
- ClinicalTrials.gov ID
- NCT05732870
- Acronym / sponsor ID
- OSTEOMICS / RRx-Profiling-001
- Conditions
- Osteoporosis, Osteoarthritis, Bone Diseases, Bone Fracture, Bone Marrow Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Relation TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Harley Street Specialist Hospital, Fitzrovia Hospital, Royal Free Hospital NHS Foundation Trust, Bedfordshire Hospitals NHS Foundation Trust, Chelsea and Westminster NHS Foundation Trust, Barts & The London NHS Trust, Royal National Orthopaedic Hospital NHS Trust
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant undergoing orthopaedic surgery | – | Procedure: Relevant 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. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants undergoing range of orthopaedic surgeries.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relevant orthopaedic surgeryInclusion criteria is purposefully broad to examine a range of discarded bone waste. Therefore, a large number of surgical interventions are relevant. | Procedure or surgery | Participant undergoing orthopaedic surgery |
Primary outcome
Acquisition of bone waste
Time frame: Within 4 hours of resection.
Discarded bone waste to be used for the study of RNA.
2 secondary outcomes
Acquisition of 10ml of blood.
Time frame: Within 4 hours of resection.
Completion of participant questionnaire
Time frame: EDC entry within 1 week of surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raghbir Khakha principal investigator
Harley Street Specialist Hospital & Fitzrovia Hospital/QASMC
Akash Patel principal investigator
Royal Free London NHS Foundation Trust
Yegappan Kalairajah principal investigator
Luton & Dunstable University Hospital, Bedfordshire Hospitals NHS Foundation Trust
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Osteoarthritis, run by Relation Therapeutics at 8 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jake Taylor-King, DPhil (447387227904, jake@relationrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acquisition of bone waste (time frame: Within 4 hours of resection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.