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

NCT ID: NCT04206033

Last Updated: 2021-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-29

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hemophilia Osteopenia Arthropathy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Observational study

Observational study

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nantes University Hospital

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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RC19_0446

Identifier Type: -

Identifier Source: org_study_id

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