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临床试验/NCT04206033
NCT04206033已完成不适用

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

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2019年11月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
73
试验地点
1
主要终点
To study the monocytic populations possibly involved in bone metabolism in hemophiliac patients.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

To study the monocytic populations possibly involved in bone metabolism in hemophiliac patients.

时间窗: 1 year

Evaluation of the inflammatory profile of patients by protein assays

次要结局

  • Find a correlation between the main objective and the measurement of bone density(1 year)
  • Look for a correlation between the main objective and physical activity(1 year)
  • Look for a correlation between the main objective and the inflammatory profile in hemophiliac patients.(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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