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

NCT04206033 | Completed

• 1 other identifier: RC19_0446
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemophilia; Osteopenia; Arthropathy

Outcome Measures

Primary Outcomes (1)

• To study the monocytic populations possibly involved in bone metabolism in hemophiliac patients.

  Evaluation of the inflammatory profile of patients by protein assays

  1 year

Secondary Outcomes (4)

• Find a correlation between the main objective and the measurement of bone density

  1 year

• Find a correlation between the main objective and the measurement of bone density

  1 year

• Look for a correlation between the main objective and physical activity

  1 year

• Look for a correlation between the main objective and the inflammatory profile in hemophiliac patients.

  1 year

Interventions

Observational study OTHER

Observational study

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, 44000, France

Location

MeSH Terms

Conditions

Hemophilia A; Bone Diseases, Metabolic; Joint Diseases

Interventions

Observation

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 20, 2019
• Study Start: November 29, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

FR (1)