Evaluation of Bone Metabolism in Children and Adolescents With Familial Mediterranean Fever

Launched by ARISTOTLE UNIVERSITY OF THESSALONIKI · Sep 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how Familial Mediterranean Fever (FMF), a condition that causes repeated episodes of inflammation, affects bone health in children and adolescents. Researchers want to find out if children with FMF have lower bone density compared to healthy kids and how different genetic mutations related to FMF may influence this. The trial aims to gather important information about bone metabolism during and after periods of inflammation.

To participate, children aged 6 and older who have been diagnosed with FMF and are currently taking a medication called colchicine for at least three months may be eligible. Healthy children of the same age can also join as a comparison group. Participants will complete questionnaires about their physical activity and health history. Throughout the study, they can expect regular assessments to evaluate their bone health. This research will help improve understanding of bone health in children with FMF and could guide future treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * 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 Criteria:
• * 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