Evaluating bone health in children with Familial Mediterranean Fever

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

This study is testing how Familial Mediterranean Fever affects bone health in children by comparing bone density in kids with the condition to healthy kids.

Quick facts

• Study type: Observational
• Enrollment: 62 (estimated)
• Ages: 6 Years to 20 Years
• Sex: All
• Sponsor: Aristotle University Of Thessaloniki (Academic / other)
• Locations: 1 site (Thessaloníki, Municipality Of Pavlou Mela)
• Trial ID: NCT06034795 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the impact of Familial Mediterranean Fever (FMF) on bone density in children and adolescents. It will involve 62 participants, including 31 children with confirmed FMF mutations and 31 healthy controls, matched by age and gender. Bone density will be measured using Dual Energy X-ray Absorptiometry (DEXA), and various factors affecting bone health, such as vitamin D levels and physical activity, will be evaluated. The study will focus on children during attack-free periods to ensure accurate results.

Who should consider this trial

Good fit: Ideal candidates include children aged 6 years and older with a confirmed diagnosis of FMF and those who are on colchicine treatment.

Not a fit: Patients under 6 years old or those experiencing active disease attacks may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better understanding and management of bone health in children with FMF.

How similar studies have performed: While there is limited data on similar studies specifically targeting bone metabolism in FMF, related research on chronic inflammation and bone health has shown promising results.

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

Where this trial is running

Thessaloníki, Municipality Of Pavlou Mela

• Papageorgiou General Hospital — Thessaloníki, Municipality Of Pavlou Mela, Greece (Recruiting)

Study contacts

• Principal investigator: Christina Chaintari, Pediatrician — Papageorgiou General Hospital
• Study coordinator: Christina Chaintari, Pediatrician

Conditions Familial Mediterranean Fever; Bone mineral density; Low vitamin D; DEXA