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Hemophilia and Bone Metabolism: Study of Monocytic Populations and Inflammatory Proteins

Hemophilia and Bone Metabolism: Study of Monocytic Populations and Inflammatory Proteins

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04206033
Acronym
BOHEM
Enrollment
73
Registered
2019-12-20
Start date
2019-11-29
Completion date
2020-12-31
Last updated
2021-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthropathy, Hemophilia, Osteopenia

Brief 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). * 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.

Interventions

OTHERObservational study

Observational study

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
To study the monocytic populations possibly involved in bone metabolism in hemophiliac patients.1 yearEvaluation of the inflammatory profile of patients by protein assays

Secondary

MeasureTime frameDescription
Find a correlation between the main objective and the measurement of bone density1 yearEvaluation of biochemical parameters involved in bone metabolism
Look for a correlation between the main objective and physical activity1 yearAssessment of physical activity by self-questionnaire
Look for a correlation between the main objective and the inflammatory profile in hemophiliac patients.1 yearEvaluation of the inflammatory profile of patients by protein assays

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026