Status:
UNKNOWN
Evaluation of Bone Metabolism in Children and Adolescents With Familial Mediterranean Fever
Lead Sponsor:
Aristotle University Of Thessaloniki
Collaborating Sponsors:
Papageorgiou General Hospital
Conditions:
Familial Mediterranean Fever
Eligibility:
All Genders
6-20 years
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...
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, gir...
Eligibility Criteria
Inclusion
- For patients:
- Age \> 6 years
- BMI 3rd - 90th percentile
- Meet the Tel Hashomer criteria (Avi Linhnen 1997)
- Confirmed diagnosis by finding mutation(s) in the MEFV gene
- Taking medication (colchicine) for at least 3 months
- Normal physical activity during the last month, according to the questionnaire that will be distributed
- Free individual history for bone diseases
- Normal thyroid function
- For the control group:
- Age \> 6 years
- BMI 3rd - 90th percentile
- Free individual history for bone diseases
- Normal physical activity according to the questionnaire
- Normal thyroid function
Exclusion
- For patients:
- Age \< 6 years
- BMI \< 3rd or \> 90th percentile
- Period of attack period of the disease
- Those who have not started treatment with colchicine
- Those who do not adapt well to taking colchicine
- Decreased physical activity during the last month according to the questionnaire
- Finding from the history of bone diseases that could affect the results
- Taking vitamins that could affect the results
- Existence of a factor that does not allow the performance of Dexa (when for example the safe and appropriate placement of the child cannot be ensured)
- History of previous surgery which forced the patient to be bedridden for a significant period of time. Possible unreliable result of bone mineral density measurement due to reduced physical activity.
- For the control group:
- Age \< 6 years
- BMI \< 3rd or \> 90th percentile
- Taking vitamins that could affect the results
- Decreased physical activity during the last month according to the questionnaire
- History of previous surgery in the last year
Key Trial Info
Start Date :
January 8 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT06034795
Start Date
January 8 2022
End Date
January 1 2025
Last Update
September 13 2023
Active Locations (1)
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1
Papageorgiou General Hospital
Thessaloniki, Municipality of Pavlou Mela, Greece, 56403