NCT05127681

Bone Microarchitecture in Men With Hemophilia

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: Male
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Hemophilia A
• Osteoporosis

Interventions

Type	Name	Description
RADIATION	HR-pQCT	Patients will have a unique HR-pQCT scanner imaging to study their bone microarchitecture
BIOLOGICAL	Blood sample	Patients will have a unique blood sampling of 10 mL for the measurements of sera PINP, CTX-I, periostin levels
RADIATION	Dual energy X-ray absorptiometry	A dual energy X-ray absorptiometry scan of lumbar spine, hip, distal radius and whole body, body composition, lateral spine will be performed.
OTHER	medical data collection	Data of healthy men is already available

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-02-06
• Completion: 2024-02-06
• First posted: 2021-11-19
• Last updated: 2024-04-18

Locations

1 site across 1 country: France