An observational study in Familial Mediterranean Fever, sponsored by Aristotle University Of Thessaloniki. Recruiting at 1 site in Greece. Open to participants aged 6 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-13.
Sponsored by Aristotle University Of Thessaloniki · Observational
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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.
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).
61 studies on the registry are indexed under Familial Mediterranean Fever; 27 are open to participants now.
This study's planned enrollment of 62 is below the median of 89 across 30 observational studies indexed under Familial Mediterranean Fever.
Browse Familial Mediterranean Fever studies →Aristotle University Of Thessaloniki is the lead sponsor of 282 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Two groups will be used: patients and control group. The results from blood examination and DEXA will be compared in order to check differences in bone mineral density betwwen the two groups.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For patients:
For the control group:
Exclusion Criteria:
For patients:
For the control group:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
32 patients with Familial mediterranenan fever will participate. In these patients we will check bone mineral density using the dexa method. Blood tests will also be taken to assess calcium metabolism. All patients will be treated with colchicine.
Healthy children will be used as control group. MEFV gene will be checked to exclude diagnosis of FMF. In these patients we will check bone mineral density using the dexa method. Blood tests will also be taken to assess calcium metabolism. The results from the two groups will be compared.
Effect of chronic inflammation of FMF on bone metabolism
This study will include 62 children, 31 healthy and 31 with FMF. All children will undergo: 1. Blood examination that will include check of calcium metabolism, Vitamin D levels, kidney function, hormonal control, thyroid function control. Biomarkers of the RANK/RANKL/OPG, which have a major role in osteoblast/osteoclast activity, will be tested. The subjects will be devided according to gender and age: 2 age groups: a) 6-12 years, b) 12 - 20 years. All the parameters will be compared to check if there is statistically significant difference between healthy children and children with FMF.
Time frame: The evaluation of bone mineral density will take place for children with FMF at attack free periods and for control group at periods that they are completely healthy. The maximun duration of the above control will be 24 hours.
Effect of chronic inflammation of FMF on bone density
All children will undergo: 2. Bone density measurment by Dual Energy X-ray Absorptiometry (the most reliable method for imaging bone density and with the minimum radiation). We will check z-score of Lumbar spine and z-score of Total Body Less Head.
Time frame: The evaluation of bone mineral density will take place for children with FMF at attack free periods and for control group at periods that they are completely healthy. The maximun duration of the above control will be 24 hours.
Effect of obesity on chronic inflammation of FMF
We will measure Body Mass Index (BMI) in all subjects. We will measure weight in kilograms (kg) and height in meters (m) to arrive at one reported value of BMI in kg/m\^2.
Time frame: The evaluation of bone mineral density will take place for children with FMF at attack free periods and for control group at periods that they are completely healthy. The maximun duration of the above control will be 24 hours.
Started Jan 2022 (actual). Primary completion is estimated for Jan 2024, 24 months after the start.
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