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

July 26, 2021 updated by: Nantes University Hospital

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

73

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44000
        • Nantes university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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