Bone Microarchitecture in Men With Hemophilia

Osteoporosis Clinical Trial

— HEMOS  

Official title:

Bone Microarchitecture in Men With Hemophilia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05127681
• Other study ID #: 69HCL19_0390
• Secondary ID: 2019-A03281-56
• Status: Terminated
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: February 6, 2024

Study information

• Verified date: April 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: February 6, 2024
• Est. primary completion date: February 6, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemophilia A
• Osteoporosis
• Severe Hemophilia A

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Cardio-Vasculaire et Pneumologique	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of trabecular at distal tibia	The number of trabecular at distal tibia will be performed and compared to the values available for the healthy control group	3 months following the inclusion
Primary	number of trabecular at distal radius	The number of trabecular at distal radius will be performed and compared to the values available for the healthy control group	3 months following the inclusion
Secondary	Sera bone remodeling biomarkers	This biomarkers will be performed: PINP (ng/ml); CTX-1 (ng/ml); Periostin (ng/ml)	3 months following the inclusion
Secondary	reflection of bone strength	Micro-Finite Element Analysis (µFEA) reflection of bone strength will be performed and compared to the values available for the healthy control group	3 months following the inclusion
Secondary	Trabecular Bone Score (TBS)	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	3 months following the inclusion