Ignite Creation Date:
2024-05-06 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05127681
Status:
TERMINATED
Last Update Posted:
2024-04-18
First Post:
2021-10-06
Brief Title:
Bone Microarchitecture in Men With Hemophilia
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Bone Microarchitecture in Men With Hemophilia
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
More Hardware
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEMOS
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 eg 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 TbN at the distal radius between hemophilic men cases and age- height-weight-ethnicity and smoking-matched healthy men controls Correlation between BTM and TbN 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
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 TbN at the distal radius between hemophilic men cases and age- height-weight-ethnicity and smoking-matched healthy men controls Correlation between BTM and TbN 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-A03281-56 | OTHER | ID-RCB | None |