Familial Mediterranean FeverFMFNCT06034795
Evaluation of Bone Metabolism in Children and Adolescents With Familial Mediterranean Fever
An observational study of Familial Mediterranean Fever, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Familial Mediterranean Fever
- How many people
- 62 participants
- Where
- 1 siteGreece
- Study dates
- 8 Jan 2022to Jan 2025
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 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.
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Papageorgiou General Hospital
Thessaloniki, Municipality of Pavlou Mela, 56403
Christina Chaintari, Pediatrician, 6970680667, christinachaintari@gmail.com
Effimia Papadopoulou, Professor, 6977813869, papadoef@auth.gr
About this study
Official title: Evaluation of Bone Metabolism in Children and Adolescents With Familial Mediterranean Fever and Correlation With Genotype
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.
Read the 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).
- Conditions
- Familial Mediterranean Fever
- Keywords
- Familial Mediterranean Fever, Bone mineral density, Low vitamin D, DEXA
- Medical subject headings
- Familial Mediterranean Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | 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. | |
| Control group | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
Measured: 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:
- 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start8 Jan 2022
- Primary completionJan 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Mediterranean FeverStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 62 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- Papageorgiou General Hospital
- Responsible party
- Sponsor
- Investigators
- Maria Fotoulaki, Professor, Study chair, Papageorgiou General HospitalEffimia Papadopoulou, Professor, Study director, Papageorgiou General HospitalChristina Chaintari, Pediatrician, Principal investigator, Papageorgiou General HospitalAssimina Galli, Professor, Study chair, AHEPA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034795
- Sponsor's protocol ID
- q3e689cu
- Acronym
- FMF
- Status last verified
- Sep 2023
- First submitted
- 5 Jun 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bone Metabolism in Children and Adolescents With Familial Mediterranean Fever and Correlation With Genotype
- ClinicalTrials.gov ID
- NCT06034795
- Acronym / sponsor ID
- FMF / q3e689cu
- Conditions
- Familial Mediterranean Fever
- Keywords
- Familial Mediterranean Fever, Bone mineral density, Low vitamin D, DEXA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- Papageorgiou General Hospital
- Study start
- 8 Jan 2022 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –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. |
| Control group | – | –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. |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (15 listed)
- For patients:
- For the control group:
Key exclusion criteria (17 listed)
- For patients:
- For the control group:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effect of chronic inflammation of FMF on bone metabolism
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.
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.
Effect of chronic inflammation of FMF on bone density
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.
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.
Effect of obesity on chronic inflammation of 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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
Related trials for Familial Mediterranean Fever
RecruitingObservational study
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
Familial Mediterranean Fever (FMF), Autoinflammation
RecruitingPhase 3
A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
Behçet's Disease, Juvenile Psoriatic Arthritis
Not yet recruitingPhase 3
Goflikicept for Resolution and Prevention of Attacks in Pediatric and Adolescent Patients With Colchicine-Resistant or Colchicine-Intolerant Familial Mediterranean Fever
Familial Mediterranean Fever, FMF
Not yet recruitingObservational study
Genotype and Phenotype in Pediatric Familial Mediterranean Fever
Familial Mediterranean Fever
Not yet recruitingObservational study
Serum EBI-3 Protein Levels in Behçet's Disease
Behçet Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Fotoulaki, Professor study chair
Papageorgiou General Hospital
Effimia Papadopoulou, Professor study director
Papageorgiou General Hospital
Christina Chaintari, Pediatrician principal investigator
Papageorgiou General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Familial Mediterranean Fever, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christina Chaintari, Pediatrician (6970680667, christinachaintari@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of chronic inflammation of FMF on bone metabolism (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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.