Fibrous Dysplasia of BoneMirDYSNCT03838991
Epigenetic Regulation in Fibrous Dysplasia of Bone: mirDYS Study.
A study testing Blood sample and Waste bone tissue in people with Fibrous Dysplasia of Bone, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Fibrous dysplasia of bone is a rare congenital but non-hereditary disease caused by a post-zygotic activation mutation of the GNAS gene. Patients with fibrous dysplasia may present pain and bone complications (fractures, deformities..) related to their bone lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrous Dysplasia of Bone
- What is being tested?
- Blood sample and Waste bone tissue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2019to 24 Mar 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Control population :
- men and women,
- 18 years-old and over,
- consulting a rheumatologist or an orthopedist for arthrosis
- have scheduled surgery for hip or knee replacement surgery or any intervention involving the lower limb or upper limb.
- Patients with Fibrous dysplasia:
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- men and women,
- 18 years-old and over,
- with a diagnosis of fibrous dysplasia previously established by a rheumatologist.
Who cannot join
- Refusal to participate in the study
- Long- term corticosteroids treatment (> 3 months)
- Treated osteoporosis
- Chronic inflammatory rheumatism (rheumatoid arthritis, psoriasic arthritis, spondyloarthropathy)
- Collagen disease (osteogenesis imperfecta…)
- Paget's disease, benign bone tumors
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- Uncontrolled hypo/hyper-thyroidism, hypo/hyper-parathryoidism
- Severe renal impairment (GFR < 30 ml/min/1.73m2)
- Cancer or bone metastases (current or in the past two years)
- Paget disease, benign bone tumor (osteoid osteoma, enchondroma …)
- Malabsorptive disease (Celiac disease, Whipple's disease, intestinal bypass, short bowel syndrome) and inflammatory bowel disease
- Pregnant women or lactating
- Psychiatric disorders
- Difficulty in understanding French
- Not a beneficiary of french social security
- Patients protected by law
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Rhumatologie & INSERM U1033, Pavillon F, Hopital Edouard Herriot
Lyon, 69437
About this study
Official title: Epigenetic Regulation of Activity and Severity of Fibrous Dysplasia in Bone: mirDYS Study.
Fibrous dysplasia of bone is a rare congenital but non-hereditary disease caused by a post-zygotic activation mutation of the GNAS gene. Patients with fibrous dysplasia may present pain and bone complications (fractures, deformities..) related to their bone lesions.
For undetermined reasons, severity and disease evolution may vary considerably from patient to patient.
Read more
Epigenetic regulation could then be involved, including micro Ribonucleic Acids (miRs).
These small non-coding micro Ribonucleic Acids are involved in the regulation of major steps of cellular processes in different pathologies, in particular in bone diseases. However, micro Ribonucleic Acids have never been studied in fibrous dysplasia.
The aim of this study is to identify micro Ribonucleic Acids significantly associated with the severity of fibrous dysplasia.
- Conditions
- Fibrous Dysplasia of Bone
- Being tested
- Blood sample, Waste bone tissue
- Medical subject headings
- Fibrous Dysplasia of Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
A study specific blood sample will be collected.
Waste bone tissueOther
For 3 patients of each group, patients having a scheduled surgery, a piece of waste bone tissue will be collected after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Monostotic fibrous dysplasia | Experimental | Patients with monostotic Fibrous dysplasia. Receives: Other: Blood sample; Other: Waste bone tissue |
| Polyostotic fibrous dysplasia | Experimental | Patients with polyostotic Fibrous dysplasia. Receives: Other: Blood sample; Other: Waste bone tissue |
| Controls | Active comparator | Control patients having a scheduled surgery for osteoarthritis. Receives: Other: Blood sample; Other: Waste bone tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of micro Ribonucleic acids expression in the serum
The objective is to identify specific microRibonucleic acids expressed in serum of patients using NGS (Next Generation Sequencing).
Measured: At inclusion
Evaluation of micro Ribonucleic acids expression in the bone tissue
The objective is to identify specific micro Ribonucleic acids expressed in bone tissue obtained from surgery (patients having a scheduled surgery for osteoarthritis or fibrous dysplasia) using NGS (Next Generation Sequencing)
Measured: At inclusion
Secondary outcomes (3)
Comparison of micro Ribonucleic acids expression
The objective is to compare nature and level of expression of the micro Ribonucleic acids identify by NGS (Next Generation Sequencing) in bone tissue and serum between the 3 groups of subjects: monostotic Fibrous Dysplasia, polyostotic Fibrous Dysplasia and controls (controls are patients with osteoarthritis).
Measured: Time of realization of the analyzes, an average of 6 months
Validation of micro Ribonucleic acids identified by NGS (Next Generation Sequencing) in blood samples
The objective is to validate expression of micro Ribonucleic acids identified by NGS (Next Generation Sequencing) in blood samples of patients from 4 pre-existing cohorts : a fibrous dysplasia cohort (PERIOSDYS) and 3 cohorts of control patients (OFELY and MODAM for women, STRAMBO for men).
For that the expression of the significant micro Ribonucleic acids identified by NGS (Next Generation Sequencing) in sera of patients with monostotic and polyostotic fibrous dysplasia versus control patients will be measured by RT-qPCR (Reverse Transcription Quantitative Polymerase Chain Reaction) and then these results will be compared with same analysis on blood samples of patients from the 4 pre-existing cohorts.
Measured: Time of realization of the analyzes, an average of 6 months
Association between micro Ribonucleic acids and severity of fibrous dysplasia.
Association between expression of significant micro Ribonucleic acids in patients with fibrous dysplasia with the severity of the disease will be studied by statistics analysis.
Severity of fibrous dysplasia will be evaluated with clinical, biological and radiological data extracted from patients' medical records (Easily software) and from the CEMARA database (fibrous dysplasia database).
Measured: Time of realization of the analyzes, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start10 Jan 2019
- Primary completion24 Mar 2023
- Study completion24 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fibrous Dysplasia of BoneStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
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
- NCT03838991
- Sponsor's protocol ID
- 69HCL18_0443
- Acronym
- MirDYS
- Status last verified
- Mar 2025
- First submitted
- 6 Feb 2019
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Legrand MA, Millet M, Merle B, Rousseau JC, Hemmendinger A, Gineyts E, Sornay-Rendu E, Szulc P, Borel O, Croset M, Chapurlat R. A Signature of Circulating miRNAs Associated With Fibrous Dysplasia of Bone: the mirDys Study. J Bone Miner Res. 2020 Oct;35(10):1881-1892. doi: 10.1002/jbmr.4111. Epub 2020 Jul 21.
PubMed 32526052
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetic Regulation of Activity and Severity of Fibrous Dysplasia in Bone: mirDYS Study.
- ClinicalTrials.gov ID
- NCT03838991
- Acronym / sponsor ID
- MirDYS / 69HCL18_0443
- Conditions
- Fibrous Dysplasia of Bone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 12 Feb 2019 (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.
Fibrous dysplasia of bone is a rare congenital but non-hereditary disease caused by a post-zygotic activation mutation of the GNAS gene. Patients with fibrous dysplasia may present pain and bone complications (fractures, deformities..) related to their bone lesions.
For undetermined reasons, severity and disease evolution may vary considerably from patient to patient.
Epigenetic regulation could then be involved, including micro Ribonucleic Acids (miRs).
These small non-coding micro Ribonucleic Acids are involved in the regulation of major steps of cellular processes in different pathologies, in particular in bone diseases. However, micro Ribonucleic Acids have never been studied in fibrous dysplasia.
The aim of this study is to identify micro Ribonucleic Acids significantly associated with the severity of fibrous dysplasia.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Monostotic fibrous dysplasia | Experimental | Other: Blood sample, Other: Waste bone tissuePatients with monostotic Fibrous dysplasia. |
| Polyostotic fibrous dysplasia | Experimental | Other: Blood sample, Other: Waste bone tissuePatients with polyostotic Fibrous dysplasia. |
| Controls | Active comparator | Other: Blood sample, Other: Waste bone tissueControl patients having a scheduled surgery for osteoarthritis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- men and women,
- 18 years-old and over,
- consulting a rheumatologist or an orthopedist for arthrosis
- have scheduled surgery for hip or knee replacement surgery or any intervention involving the lower limb or upper limb.
- men and women,
Key exclusion criteria (16 listed)
- Refusal to participate in the study
- Long- term corticosteroids treatment (> 3 months)
- Treated osteoporosis
- Chronic inflammatory rheumatism (rheumatoid arthritis, psoriasic arthritis, spondyloarthropathy)
- Collagen disease (osteogenesis imperfecta…)
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 |
|---|---|---|
| Blood sampleA study specific blood sample will be collected. | Other | Controls, Monostotic fibrous dysplasia, Polyostotic fibrous dysplasia |
| Waste bone tissueFor 3 patients of each group, patients having a scheduled surgery, a piece of waste bone tissue will be collected after surgery. | Other | Controls, Monostotic fibrous dysplasia, Polyostotic fibrous dysplasia |
Primary outcome
Evaluation of micro Ribonucleic acids expression in the serum
Time frame: At inclusion
The objective is to identify specific microRibonucleic acids expressed in serum of patients using NGS (Next Generation Sequencing).
Evaluation of micro Ribonucleic acids expression in the bone tissue
Time frame: At inclusion
The objective is to identify specific micro Ribonucleic acids expressed in bone tissue obtained from surgery (patients having a scheduled surgery for osteoarthritis or fibrous dysplasia) using NGS (Next Generation Sequencing)
3 secondary outcomes
Comparison of micro Ribonucleic acids expression
Time frame: Time of realization of the analyzes, an average of 6 months
Validation of micro Ribonucleic acids identified by NGS (Next Generation Sequencing) in blood samples
Time frame: Time of realization of the analyzes, an average of 6 months
Association between micro Ribonucleic acids and severity of fibrous dysplasia.
Time frame: Time of realization of the analyzes, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Results publication: PubMed 32526052Legrand MA, Millet M, Merle B, Rousseau JC, Hemmendinger A, Gineyts E, Sornay-Rendu E, Szulc P, Borel O, Croset M, Chapurlat R. A Signature of Circulating miRNAs Associated With Fibrous Dysplasia of Bone: the mirDys Study. J Bone Miner Res. 2020 Oct;35(10):1881-1892. doi: 10.1002/jbmr.4111. Epub 2020 Jul 21.
- Individual participant dataSharing planned: No
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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?
A study testing Blood sample and Waste bone tissue in people with Fibrous Dysplasia of Bone, 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 9 inclusion and 16 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: finished, as of the sponsor's last update on 4 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of micro Ribonucleic acids expression in the serum (time frame: At inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03838991, which also lists 1 linked publication.
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 4 Sep 2025.