Brief Title
Bone Microarchitecture in Men With Hemophilia
Official Title
Bone Microarchitecture in Men With Hemophilia
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 Type
Interventional
Primary Outcome
number of trabecular at distal tibia
Secondary Outcome
Sera bone remodeling biomarkers
Condition
Severe Hemophilia A
Intervention
HR-pQCT
Study Arms / Comparison Groups
severe hemophilia A or B patients
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Radiation
Estimated Enrollment
30
Start Date
March 1, 2022
Completion Date
June 1, 2024
Primary Completion Date
June 1, 2024
Eligibility Criteria
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.
Gender
Male
Ages
20 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
, 0472118810, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT05127681
Organization ID
69HCL19_0390
Secondary IDs
2019-A03281-56
Responsible Party
Sponsor
Study Sponsor
Hospices Civils de Lyon
Study Sponsor
, ,
Verification Date
February 2022