Bone Microarchitecture in Men With Hemophilia (HEMOS)

Civil Hospices of Lyon

Status: Terminated

Conditions: Osteoporosis; Severe Hemophilia A

Treatments: Radiation: HR-pQCT; Biological: Blood sample; Other: medical data collection; Radiation: Dual energy X-ray absorptiometry

Study type: Interventional

Funder types: Other

Identifiers

NCT05127681

69HCL19_0390

2019-A03281-56 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Male

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients:

• Men aged 20 to 60 years
• Severe hemophilia A or B (FVIII or FIX<1%)
• Regular followed up in Lyon Hemophilia Center
• Ability to give free and informed consent
• Person capable of actively participating in radiological examinations

Healthy Mens:

• Aged 20 to 60 years

Exclusion criteria

• Women
• Not covered by health system
• Vulnerable (adults unable to consent, protected under guardianship, prisoner)
• Any blood coagulation abnormality other than severe hemophilia A or B
• Having one of the following treatments against osteoporosis of more than 6 months : bisphosphonates, denosumab, teriparatide
• With a chronical disease having a high impact on bone structure and no related to hemophilia disease, such as Cushing or Crohn diseases.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

severe hemophilia A or B patients

Experimental group

Description:

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.

Treatment:

Biological: Blood sample

Radiation: HR-pQCT

Radiation: Dual energy X-ray absorptiometry

healthy men

Other group

Description:

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.

Treatment:

Other: medical data collection