Bone Microarchitecture in Men With Hemophilia (HEMOS)
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bron, France, 69677
- Hôpital Cardio-Vasculaire et Pneumologique
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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Patients will have a unique HR-pQCT scanner imaging to study their bone microarchitecture
Patients will have a unique blood sampling of 10 mL for the measurements of sera PINP, CTX-I, periostin levels
A dual energy X-ray absorptiometry scan of lumbar spine, hip, distal radius and whole body, body composition, lateral spine will be performed.
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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.
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Data of healthy men is already available
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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number of trabecular at distal tibia
Time Frame: 3 months following the inclusion
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The number of trabecular at distal tibia will be performed and compared to the values available for the healthy control group
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3 months following the inclusion
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number of trabecular at distal radius
Time Frame: 3 months following the inclusion
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The number of trabecular at distal radius will be performed and compared to the values available for the healthy control group
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3 months following the inclusion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sera bone remodeling biomarkers
Time Frame: 3 months following the inclusion
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This biomarkers will be performed:
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3 months following the inclusion
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reflection of bone strength
Time Frame: 3 months following the inclusion
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Micro-Finite Element Analysis (µFEA) reflection of bone strength will be performed and compared to the values available for the healthy control group
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3 months following the inclusion
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Trabecular Bone Score (TBS)
Time Frame: 3 months following the inclusion
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Trabecular Bone Score (TBS) will be performed and compared to the values available for the healthy control group The trabecular bone score is a measure of bone texture correlated with bone microarchitecture and a marker for the risk of osteoporosis
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3 months following the inclusion
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL19_0390
- 2019-A03281-56 (Other Identifier: ID-RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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