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

Osteopenia Clinical Trial

— BOHEM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04206033
• Other study ID #: RC19_0446
• Status: Completed
• Start date: November 29, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthropathy
• Bone Diseases, Metabolic
• Hemophilia
• Hemophilia A
• Joint Diseases
• Osteopenia

Intervention

Other:
• Observational study
Observational study

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

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