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

Completed

• Conditions: Hemophilia; Osteopenia; Arthropathy

• Registration Number: NCT04206033
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-29
• Study First Submitted: 2019-12-18
• Study First Submitted QC: 2019-12-18
• Study First Posted: 2019-12-20
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 73

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the monocytic populations possibly involved in bone metabolism in hemophiliac patients.	1 year	Evaluation of the inflammatory profile of patients by protein assays

Secondary Outcome Measures

Name	Time	Method
Find a correlation between the main objective and the measurement of bone density	1 year	Non-invasive bone mineral density measurement
Look for a correlation between the main objective and physical activity	1 year	Assessment of physical activity by self-questionnaire
Look for a correlation between the main objective and the inflammatory profile in hemophiliac patients.	1 year	Evaluation of the inflammatory profile of patients by protein assays

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France