Bone Microarchitecture in Men With Hemophilia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- number of trabecular at distal tibia
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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.
Outcomes
Primary Outcomes
number of trabecular at distal tibia
Time Frame: 3 months following the inclusion
The number of trabecular at distal tibia will be performed and compared to the values available for the healthy control group
number of trabecular at distal radius
Time Frame: 3 months following the inclusion
The number of trabecular at distal radius will be performed and compared to the values available for the healthy control group
Secondary Outcomes
- reflection of bone strength(3 months following the inclusion)
- Sera bone remodeling biomarkers(3 months following the inclusion)
- Trabecular Bone Score (TBS)(3 months following the inclusion)