Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
10 participants
INTERVENTIONAL
2023-08-01
2024-02-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Osteoporosis and MRI Study in Hemophilia
NCT01460147
Radiological Biological Genetic and Micro-architectural Bone Determinants of Fractures in Men With Low Bone Mineral Density
NCT01250314
Osteoporosis and Haemophilia
NCT04524481
Mother Daughter Bone Microarchitecture
NCT01258036
Bone Microarchitecture in Women With and Without Fracture
NCT01049191
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
HR-pQCT
Patients will have a unique HR-pQCT scanner imaging to study their bone microarchitecture
Blood sample
Patients will have a unique blood sampling of 10 mL for the measurements of sera PINP, CTX-I, periostin levels
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.
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.
medical data collection
Data of healthy men is already available
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HR-pQCT
Patients will have a unique HR-pQCT scanner imaging to study their bone microarchitecture
Blood sample
Patients will have a unique blood sampling of 10 mL for the measurements of sera PINP, CTX-I, periostin levels
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.
medical data collection
Data of healthy men is already available
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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.
20 Years
60 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospices Civils de Lyon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hôpital Cardio-Vasculaire et Pneumologique
Bron, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-A03281-56
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL19_0390
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.