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

Sponsor

Nantes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04206033

Collaborator

(none)

Enrollment

Location

13.1

Actual Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemophilia Osteopenia Arthropathy	Other: Observational study

Study Design

Study Type:

Observational

Actual Enrollment :

73 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 29, 2019

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Outcome Measures

Primary Outcome Measures

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

Find a correlation between the main objective and the measurement of bone density [1 year]
Evaluation of biochemical parameters involved in bone metabolism
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nantes University Hospital	Nantes		France	44000

Sponsors and Collaborators

Nantes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT04206033

Other Study ID Numbers:

RC19_0446

First Posted:

Dec 20, 2019

Last Update Posted:

Jul 27, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Bone Diseases, Metabolic

Hemophilia A

Study Results

No Results Posted as of Jul 27, 2021