Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-30 @ 9:15 PM
Study NCT ID:
NCT06034795
Status:
UNKNOWN
Last Update Posted:
2023-09-13
First Post:
2023-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Bone Metabolism in Children and Adolescents With Familial Mediterranean Fever
Sponsor:
Aristotle University Of Thessaloniki
Organization:
Study Overview
Official Title:
Evaluation of Bone Metabolism in Children and Adolescents With Familial Mediterranean Fever and Correlation With Genotype
Status:
UNKNOWN
Status Verified Date:
2023-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FMF
Brief Summary:
Familial Mediterranean Fever is a chronic auto-inflammatory disease. In the context of chronic inflammation, it seems that, among others, it also affects bone density in children. Bone loss may be due to subclinical inflammation that persists even during periods of remission. In addition, inflammatory cytokines also play an important role (mainly during episodes) resulting in an increase in bone degradation and ultimately a reduction in bone mass. Cytokines mainly associated with bone degradation and osteoclast activity are: IL-1R, IL-2, IL-6, IL-8, TNFa.
The purpose of this study is to determine the effect of FMF on bone density and to compare the results with a healthy population. In addition, the difference between the children with FMF will be studied according to the mutation they carry.
The purpose of this study is to determine the effect of FMF on bone density and to compare the results with a healthy population. In addition, the difference between the children with FMF will be studied according to the mutation they carry.
Detailed Description:
For the above purpose, 62 children will participate, 31 healthy and 31 with FMF(confirmed mutation/s in the MEFV (Marenostrin Encoding Fever Gene) ).
They will be separated based on gender (boys, girls) and age: 2 age groups: a) 6-12 years, b) 12 - 20 years, separation into pre-adolescent children and adolescents (according to Tanner) and Body Mass Index ( BMI) (3rd-90th ED). Of the 31 children with FMF, all will be treated with colchicine and the study will not take place during periods of disease attack.
An attack free period is defined as a period of at least 3 weeks without clinical symptoms (fever, abdominal pain, arthritis) and without acute phase indicators (increased CRP, TKE, WBC).
The healthy population will exclude children with a history of disease related to a bone disorder. In addition, the existence of other factors that could affect bone density will be investigated in all 62 children. For this reason, there will be a check of calcium metabolism, vitamin D, kidney function, hormonal check, thyroid function check. Biomarkers of the RANK/RANKL/OPG axis that have a major role in osteoblast/osteoclast activity will be tested. Children's physical activity will be also assessed.
Bone density measurement will be done with a Hologic DISCOVERY QDR DXA (Dual Energy X-ray Absorptiometry) machine, the "gold standard" for spine and hip bone disorder screening worldwide. The program to be implemented will be adapted to childhood.
Then the following will be assessed: Body Mineral Density (BMD), Body Mineral Content (BMC) and z-score for the vertebrae of the OMSS (O1-O4) and Total Body less Head (TBLH).
They will be separated based on gender (boys, girls) and age: 2 age groups: a) 6-12 years, b) 12 - 20 years, separation into pre-adolescent children and adolescents (according to Tanner) and Body Mass Index ( BMI) (3rd-90th ED). Of the 31 children with FMF, all will be treated with colchicine and the study will not take place during periods of disease attack.
An attack free period is defined as a period of at least 3 weeks without clinical symptoms (fever, abdominal pain, arthritis) and without acute phase indicators (increased CRP, TKE, WBC).
The healthy population will exclude children with a history of disease related to a bone disorder. In addition, the existence of other factors that could affect bone density will be investigated in all 62 children. For this reason, there will be a check of calcium metabolism, vitamin D, kidney function, hormonal check, thyroid function check. Biomarkers of the RANK/RANKL/OPG axis that have a major role in osteoblast/osteoclast activity will be tested. Children's physical activity will be also assessed.
Bone density measurement will be done with a Hologic DISCOVERY QDR DXA (Dual Energy X-ray Absorptiometry) machine, the "gold standard" for spine and hip bone disorder screening worldwide. The program to be implemented will be adapted to childhood.
Then the following will be assessed: Body Mineral Density (BMD), Body Mineral Content (BMC) and z-score for the vertebrae of the OMSS (O1-O4) and Total Body less Head (TBLH).
Study Oversight
Has Oversight DMC:
False
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?: