Civil Hospices of Lyon
Hemophilia A and B are hereditary sex-linked deficiencies of coagulation factors VIII and IX characterized by bleeding. Their modern therapy increases life expectancy and risk of age-related diseases, e.g., osteoporosis. Hemophilia-specific risk factors impair formation of peak bone mass and accelerate bone loss. Fractures are more frequent in hemophilic men vs. age-matched men and induce bleeding which is aggravated by manipulations and surgical intervention. The hypothesis of this study is that hemophilic men have poor bone microarchitecture (assessed by High-resolution peripheral quantitative computed tomography (HR-pQCT)) related to an imbalance between bone formation and resorption (assessed by bone turnover markers (BTM) and bone biomarkers). The study aims to assess the difference in low trabecular number (Tb.N) at the distal radius between hemophilic men (cases) and age- height-weight-ethnicity and smoking-matched healthy men (controls). Correlation between BTM and Tb.N will be also studied. Biologic markers of bone remodeling (C-terminal telopeptide of type I collagen (PINP), N-terminal propeptide of type I procollagen (CTX-I), periostin) will be studied.
Severe Hemophilia A
Osteoporosis
HR-pQCT
Blood sample
Dual energy X-ray absorptiometry
medical data collection
Not Applicable
| Study Type : | Interventional |
| Estimated Enrollment : | 10 participants |
| Masking : | None (Open Label) |
| Primary Purpose : | Diagnostic |
| Official Title : | Bone Microarchitecture in Men With Hemophilia |
| Actual Study Start Date : | August 1, 2023 |
| Estimated Primary Completion Date : | February 6, 2024 |
| Estimated Study Completion Date : | February 6, 2024 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: severe hemophilia A or B patients 30 patients with severe hemophilia A or B (Factor (F)VIII or Factor IX (FIX)≤ 1%) aged 20 to 60 years will be included in this study. |
Radiation: HR-pQCT Biological: Blood sample |
|
Other: healthy men Data of healthy men, matching in age- height-weight-ethnicity and smoking-matched with patient will be collected. These data are already available at the "Institut national de la santé et de la recherche médicale" (INSERM) research unit associated. |
Radiation: Dual energy X-ray absorptiometry Other: medical data collection |
| Ages Eligible for Study: | 20 Years to 60 Years |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Cardiovascular and Pneumological Hospital
Bron, France, 69677