HemophiliaBOHEMNCT04206033
Hemophilia and Bone Metabolism: Study of Monocytic Populations and Inflammatory Proteins
An observational study of Hemophilia and Osteopenia, run by Nantes University Hospital at 1 site in France.
Trial summary
The investigators propose, as part of the study, to carry out for each patient: An analysis of monocytic populations by flow cytometry (CD14, CD16, CD45, CD68, CD115, CCR2, CX3CR1, CD163 and CD206). A population assessment of Myeloid-Derived Suppressor Cells (MDSC). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hemophilia, Osteopenia, Arthropathy
- What is being tested?
- Observational study
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2019to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: It will include adult male patients with hemophilia A or B, severe, moderate or minor. In addition, the investigators will include patients with Hemophilia A with an inhibitor.
Who may be able to join
- Major patients followed at the hemophilia treatment reference center,
- Presenting the diagnosis of severe, moderate or minor Hemophilia A / B,
- Having a social security system,
- Obtaining the oral non-objection collection from the patient after information.
Who cannot join
- Minor patients, under guardianship or curatorship.
- Causes of secondary osteoporosis:
- Systemic corticosteroid therapy in progress (≥ 3 consecutive months, at a dosage ≥ 7.5 mg / d of prednisone equivalent).
- other treatment or condition responsible for osteoporosis: prolonged or medicated hypogonadism, untreated active hyperthyroidism, hypercorticism, primary hyperparathyroidism.
- Treatment with biphosphonates, biotherapies or hormone therapy in the treatment of prostate cancer.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators propose, as part of the study, to carry out for each patient:
- An analysis of monocytic populations by flow cytometry (CD14, CD16, CD45, CD68, CD115, CCR2, CX3CR1, CD163 and CD206).
- A population assessment of Myeloid-Derived Suppressor Cells (MDSC).
- Assays of cytokines and chemokines involved in inflammation by multiplex analyzes: Il-1 (α and β), Il-4, Il-6, Il-10, Il-13, TNF- α, TGF- β, CRP , leptin, IFN- β.
- Specialized dosages of proteins involved in bone metabolism. RANKL, osteoprotegerin, M-CSF, TRAPCP5.
- Conditions
- Hemophilia, Osteopenia, Arthropathy
- Being tested
- Observational study
- Medical subject headings
- Hemophilia A, Bone Diseases, Metabolic, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the monocytic populations possibly involved in bone metabolism in hemophiliac patients.
Evaluation of the inflammatory profile of patients by protein assays
Measured: 1 year
Secondary outcomes (4)
Find a correlation between the main objective and the measurement of bone density
Evaluation of biochemical parameters involved in bone metabolism
Measured: 1 year
Find a correlation between the main objective and the measurement of bone density
Non-invasive bone mineral density measurement
Measured: 1 year
Look for a correlation between the main objective and physical activity
Assessment of physical activity by self-questionnaire
Measured: 1 year
Look for a correlation between the main objective and the inflammatory profile in hemophiliac patients.
Evaluation of the inflammatory profile of patients by protein assays
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start29 Nov 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206033
- Sponsor's protocol ID
- RC19_0446
- Acronym
- BOHEM
- Status last verified
- Jul 2021
- First submitted
- 18 Dec 2019
- Last updated
- 27 Jul 2021
- 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 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemophilia and Bone Metabolism: Study of Monocytic Populations and Inflammatory Proteins
- ClinicalTrials.gov ID
- NCT04206033
- Acronym / sponsor ID
- BOHEM / RC19_0446
- Conditions
- Hemophilia, Osteopenia, Arthropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 29 Nov 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 20 Dec 2019 (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.
The investigators propose, as part of the study, to carry out for each patient:
- An analysis of monocytic populations by flow cytometry (CD14, CD16, CD45, CD68, CD115, CCR2, CX3CR1, CD163 and CD206).
- A population assessment of Myeloid-Derived Suppressor Cells (MDSC).
- Assays of cytokines and chemokines involved in inflammation by multiplex analyzes: Il-1 (α and β), Il-4, Il-6, Il-10, Il-13, TNF- α, TGF- β, CRP , leptin, IFN- β.
- Specialized dosages of proteins involved in bone metabolism. RANKL, osteoprotegerin, M-CSF, TRAPCP5.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It will include adult male patients with hemophilia A or B, severe, moderate or minor. In addition, the investigators will include patients with Hemophilia A with an inhibitor.
Key inclusion criteria (4 listed)
- Major patients followed at the hemophilia treatment reference center,
- Presenting the diagnosis of severe, moderate or minor Hemophilia A / B,
- Having a social security system,
- Obtaining the oral non-objection collection from the patient after information.
Key exclusion criteria (5 listed)
- Minor patients, under guardianship or curatorship.
- Causes of secondary osteoporosis:
- Treatment with biphosphonates, biotherapies or hormone therapy in the treatment of prostate cancer.
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 |
|---|---|---|
| Observational studyObservational study | Other | – |
Primary outcome
To study the monocytic populations possibly involved in bone metabolism in hemophiliac patients.
Time frame: 1 year
Evaluation of the inflammatory profile of patients by protein assays
4 secondary outcomes
Find a correlation between the main objective and the measurement of bone density
Time frame: 1 year
Find a correlation between the main objective and the measurement of bone density
Time frame: 1 year
Look for a correlation between the main objective and physical activity
Time frame: 1 year
Look for a correlation between the main objective and the inflammatory profile in hemophiliac patients.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Hemophilia and Osteopenia, run by Nantes University Hospital at 1 site in France.
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 4 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: finished, as of the sponsor's last update on 27 Jul 2021. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study the monocytic populations possibly involved in bone metabolism in hemophiliac patients. (time frame: 1 year). 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 27 Jul 2021.