Fibrous Dysplasia/McCune-Albright SyndromeMEKADYSNCT07507942
Assessment of Femoral Failure Load and Fracture Risk in Rare Bone Disorders Using MEKANOS Tool. Case Study of Fibrous Dysplasia of Bone/McCune Albright Syndrome
An observational study of Fibrous Dysplasia/McCune-Albright Syndrome, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The issue of rare diseases has become a public health priority. In France, a national plan for rare diseases was published in 2004. It leads to the creation and certification of numerous Rare Disease Reference Centers by the French National Authority for Health (Haute Autorité de Santé). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrous Dysplasia/McCune-Albright Syndrome
- What is being tested?
- Application of MEKANOS tool to CT scans
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2025to 10 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinical data issued from Easily HYBRID DF Database, and CT images of long bones acquired during routine clinical care and retrieved from the HCL imaging..
Who may be able to join
- Adults with Fibrous Dysplasia (FD) of the bone or McCune-Albright Syndrome (MAS);
- who have received care at the center through outpatient consultation, multidisciplinary evaluation, or hospitalization;
- whose diagnosis was confirmed by an expert physician from the reference center based on a combination of clinical, biochemical, and radiological criteria, in accordance with the recommendations of the international FD/MAS consortium (Javaid MK et al., Orphanet J Rare Dis. 2019);
- for whom a histological confirmation was obtained in cases of diagnostic uncertainty;
- no objection to data collection
Who cannot join
- - CT scan with implanted material on the femur,
- Individuals under legal protection measures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Femoral Failure Load and Fracture Risk in Rare Bone Disorders Using MEKANOS Tool. Case Study of Fibrous Dysplasia of Bone/McCune Albright Syndrome. MEKADYS Study
The issue of rare diseases has become a public health priority. In France, a national plan for rare diseases was published in 2004. It leads to the creation and certification of numerous Rare Disease Reference Centers by the French National Authority for Health (Haute Autorité de Santé).
Our Fibrous Dysplasia Reference Center has been certified since 2006. However, evaluating the mechanical strength and fracture risk of fibrous dysplasia lesions remains a major unresolved challenge for clinicians. Improving the assessment of fracture risk therefore represents a key clinical objective.
- Being tested
- Application of MEKANOS tool to CT scans
- Keywords
- Fibrous dysplasia, McCune Albright, MEKANOS tool, MAS-DF, bone disease, fracture risk in rare bone disease
- Medical subject headings
- Fibrous Dysplasia of Bone, Fibrous Dysplasia, Polyostotic, Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of MEKANOS tool to CT scansOther
MEKANOS tool is an algorithm that automatically segments femurs from clinical CT scans, generates a numerical model, and performs a numerical simulation of single leg stance loading on these femurs. The tool is developed within INSERM unit 1033 and is currently available only in the laboratory. Input data consist of CT imaging (DICOM format) and retrospective clinical data. The output is the failure load expressed in Newtons.Interpretation of the results involves determining fracture risk based on the failure load (pathological bone versus healthy bone), and then integrating patient size and weight. CT Scans are issued from the HCL PACS, and clinical data issued from Easily Hybrid DF database.
| Study group | Role | What they receive |
|---|---|---|
| CT scans of Patients with femoral fibrous dysplasia lesions identified in the Easily HYBRID DF datab | Application of MEKANOS tool to CT scans. Receives: Other: Application of MEKANOS tool to CT scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tool X
Obtaining an image suitable for processing with tool X in order to compute failure strength through numerical simulation (i.e., adequate bone segmentation and a correctly implemented numerical model with appropriate boundary conditions).
Measured: CT scans of Patients with femoral fibrous dysplasia lesions performed from January 2002 until 9 March 2025.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start10 Mar 2025
- Primary completion10 Mar 2026
- Study completion10 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrous Dysplasia/McCune-Albright SyndromeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507942
- Sponsor's protocol ID
- 69HCL25_0493
- Other IDs
- 25-5106
- Acronym
- MEKADYS
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 2 Apr 2026
- 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 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Femoral Failure Load and Fracture Risk in Rare Bone Disorders Using MEKANOS Tool. Case Study of Fibrous Dysplasia of Bone/McCune Albright Syndrome. MEKADYS Study
- ClinicalTrials.gov ID
- NCT07507942
- Acronym / sponsor ID
- MEKADYS / 69HCL25_0493
- Keywords
- Fibrous dysplasia, McCune Albright, MEKANOS tool, MAS-DF, bone disease, fracture risk in rare bone disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- 10 Mar 2027 (estimated)
- First posted
- 2 Apr 2026 (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.
The issue of rare diseases has become a public health priority. In France, a national plan for rare diseases was published in 2004. It leads to the creation and certification of numerous Rare Disease Reference Centers by the French National Authority for Health (Haute Autorité de Santé).
Our Fibrous Dysplasia Reference Center has been certified since 2006. However, evaluating the mechanical strength and fracture risk of fibrous dysplasia lesions remains a major unresolved challenge for clinicians. Improving the assessment of fracture risk therefore represents a key clinical objective.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT scans of Patients with femoral fibrous dysplasia lesions identified in the Easily HYBRID DF datab | – | Other: Application of MEKANOS tool to CT scansApplication of MEKANOS tool to CT scans. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical data issued from Easily HYBRID DF Database, and CT images of long bones acquired during routine clinical care and retrieved from the HCL imaging..
Key inclusion criteria (5 listed)
- Adults with Fibrous Dysplasia (FD) of the bone or McCune-Albright Syndrome (MAS);
- who have received care at the center through outpatient consultation, multidisciplinary evaluation, or hospitalization;
- whose diagnosis was confirmed by an expert physician from the reference center based on a combination of clinical, biochemical, and radiological criteria, in accordance with the recommendations of the international FD/MAS consortium (Javaid MK et al., Orphanet J Rare Dis. 2019);
- for whom a histological confirmation was obtained in cases of diagnostic uncertainty;
- no objection to data collection
Key exclusion criteria (2 listed)
- - CT scan with implanted material on the femur,
- Individuals under legal protection measures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of MEKANOS tool to CT scansMEKANOS tool is an algorithm that automatically segments femurs from clinical CT scans, generates a numerical model, and performs a numerical simulation of single leg stance loading on these femurs. The tool is developed within INSERM unit 1033 and is currently available only in the laboratory. Input data consist of CT imaging (DICOM format) and retrospective clinical data. The output is the failure load expressed in Newtons.Interpretation of the results involves determining fracture risk based on the failure load (pathological bone versus healthy bone), and then integrating patient size and weight. CT Scans are issued from the HCL PACS, and clinical data issued from Easily Hybrid DF database. | Other | CT scans of Patients with femoral fibrous dysplasia lesions identified in the Easily HYBRID DF datab |
Primary outcome
Tool X
Time frame: CT scans of Patients with femoral fibrous dysplasia lesions performed from January 2002 until 9 March 2025.
Obtaining an image suitable for processing with tool X in order to compute failure strength through numerical simulation (i.e., adequate bone segmentation and a correctly implemented numerical model with appropriate boundary conditions).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fibrous Dysplasia/McCune-Albright Syndrome, run by Hospices Civils de Lyon at 1 site in France.
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 5 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tool X (time frame: CT scans of Patients with femoral fibrous dysplasia lesions performed from January 2002 until 9 March 2025.). 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 2 Apr 2026.