Hemophilia and Bone Metabolism: Study of Monocytic Populations and Inflammatory Proteins (BOHEM)

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 Overview

• Status: Completed
• Conditions: Hemophilia; Arthropathy; Osteopenia
• Intervention / Treatment: Other: Observational study

• Study Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44000
    • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Find a correlation between the main objective and the measurement of bone density	Evaluation of biochemical parameters involved in bone metabolism	1 year
Find a correlation between the main objective and the measurement of bone density	Non-invasive bone mineral density measurement	1 year
Look for a correlation between the main objective and physical activity	Assessment of physical activity by self-questionnaire	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	1 year

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: December 18, 2019
• First Posted (Actual): December 20, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Musculoskeletal Diseases; Bone Diseases; Blood Coagulation Disorders; Hemophilia A; Bone Diseases, Metabolic
• Other Study ID Numbers: RC19_0446

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No