OsteoporosisNCT05246813
Metabolic Profiling of Hematopoietic Stem Cells in Clonal Hematopoiesis (CHIP)
An observational study of Osteoporosis and Osteoarthritis, Hip, run by Imelda Hospital, Bonheiden at 1 site in Belgium.
Trial summary
Bone marrow samples will be collected from patients undergoing hip arthroplasty surgery. Blood and bone marrow samples will be used for metabolic profiling and analysis of relevant CHIP mutations. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Osteoporosis, Osteoarthritis, Hip, Hip Fractures
- What is being tested?
- Blood and bone marrow cell collection
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Feb 2022to 31 Dec 2030
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing hip arthroplasty for hip osteoarthritis or osteoporotic hip fractures.
Who may be able to join
- Age 65 years and older
Who cannot join
- known haematological condition (myelodysplasia, leukemia, cancer)
- inability to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Imelda Hospital
Bonheiden, België, 2820
Michaël R. Laurent, MD PhD, +32485143267, michael.laurent@imelda.be
Hans Casteur, MD
About this study
Official title: Metabolic Profiling of Hematopoietic Stem Cells in Clonal Hematopoiesis (CHIP): a Prospective Observational Study
Bone marrow samples will be collected from patients undergoing hip arthroplasty surgery. Blood and bone marrow samples will be used for metabolic profiling and analysis of relevant CHIP mutations. Combined single-cell transcriptomics and mutation-specific single-cell genotyping (biotin-PCR using mutation-targeted primers followed by sequencing) will subsequently be performed. The gene expression profile of wildtype and mutant hematopoietic stem cells will be compared, performing both broad gene set enrichment analysis and targeted analysis of metabolic pathways.
- Conditions
- Osteoporosis, Osteoarthritis, Hip, Hip Fractures, Clonal Hematopoiesis of Indeterminate Potential, Aging
- Being tested
- Blood and bone marrow cell collection
- Medical subject headings
- Osteoporosis, Osteoarthritis, Hip, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and bone marrow cell collectionOther
Collection of blood and bone marrow
| Study group | Role | What they receive |
|---|---|---|
| Osteoporotic hip fracture patients | Not described Receives: Other: Blood and bone marrow cell collection | |
| Hip osteoarthritis patients | Not described Receives: Other: Blood and bone marrow cell collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene Set Enrichment Analysis (GSEA) Normalized Enrichment Score (NES)
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start11 Feb 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (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-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imelda Hospital, Bonheiden
- Sponsor type
- University, hospital or other
- Collaborators
- Université Catholique de Louvain
- Responsible party
- Principal investigator, Michaël R Laurent, MD PhD, Imelda Hospital, Bonheiden
- Investigators
- Nick Van Gastel, PhD, Principal investigator, de Duve Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246813
- Sponsor's protocol ID
- 20211214
- Status last verified
- Mar 2026
- First submitted
- 10 Feb 2022
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Profiling of Hematopoietic Stem Cells in Clonal Hematopoiesis (CHIP): a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05246813
- Acronym / sponsor ID
- 20211214
- Conditions
- Osteoporosis, Osteoarthritis, Hip, Hip Fractures, Clonal Hematopoiesis of Indeterminate Potential, Aging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Imelda Hospital, BonheidenUniversity, hospital or other
- Collaborators
- Université Catholique de Louvain
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 18 Feb 2022 (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.
Bone marrow samples will be collected from patients undergoing hip arthroplasty surgery. Blood and bone marrow samples will be used for metabolic profiling and analysis of relevant CHIP mutations. Combined single-cell transcriptomics and mutation-specific single-cell genotyping (biotin-PCR using mutation-targeted primers followed by sequencing) will subsequently be performed. The gene expression profile of wildtype and mutant hematopoietic stem cells will be compared, performing both broad gene set enrichment analysis and targeted analysis of metabolic pathways.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteoporotic hip fracture patients | – | Other: Blood and bone marrow cell collection |
| Hip osteoarthritis patients | – | Other: Blood and bone marrow cell collection |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing hip arthroplasty for hip osteoarthritis or osteoporotic hip fractures.
Key inclusion criteria (1 listed)
- Age 65 years and older
Key exclusion criteria (2 listed)
- known haematological condition (myelodysplasia, leukemia, cancer)
- inability to provide written informed consent
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 |
|---|---|---|
| Blood and bone marrow cell collectionCollection of blood and bone marrow | Other | Hip osteoarthritis patients, Osteoporotic hip fracture patients |
Primary outcome
Gene Set Enrichment Analysis (GSEA) Normalized Enrichment Score (NES)
Time frame: One day
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 25 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Nick Van Gastel, PhD principal investigator
de Duve Institute
1 site 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, Hip, run by Imelda Hospital, Bonheiden at 1 site in Belgium.
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 1 inclusion and 2 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 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 Michaël R. Laurent, MD PhD (+32485143267, michael.laurent@imelda.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene Set Enrichment Analysis (GSEA) Normalized Enrichment Score (NES) (time frame: One day). 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 25 Mar 2026.