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Completed

NCT Number: NCT04206033

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

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.

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Key information

Conditions

Hemophilia Arthropathy Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Bone Diseases Bone Diseases, Metabolic Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders Joint Diseases Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteopenia

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Nantes University Hospital

Nantes, 44000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

observational study

Other

Observational study

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

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

    Time frame: 1 year

    Non-invasive bone mineral density measurement

  3. Look for a correlation between the main objective and physical activity

    Time frame: 1 year

    Assessment of physical activity by self-questionnaire

  4. 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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: BOHEM

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 20, 2019
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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