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Epigenetic Regulation in Fibrous Dysplasia of Bone: mirDYS Study. (MirDYS)

Primary Purpose

Fibrous Dysplasia of Bone

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Waste bone tissue
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fibrous Dysplasia of Bone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:

  • men and women,
  • 18 years-old and over,
  • with a diagnosis of fibrous dysplasia previously established by a rheumatologist.

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Service de Rhumatologie & INSERM U1033, Pavillon F, Hopital Edouard HerriotRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Monostotic fibrous dysplasia

Polyostotic fibrous dysplasia

Controls

Arm Description

Patients with monostotic Fibrous dysplasia.

Patients with polyostotic Fibrous dysplasia.

Control patients having a scheduled surgery for osteoarthritis.

Outcomes

Primary Outcome Measures

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).
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)

Secondary Outcome Measures

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).
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.
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).

Full Information

First Posted
February 6, 2019
Last Updated
January 3, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03838991
Brief Title
Epigenetic Regulation in Fibrous Dysplasia of Bone: mirDYS Study.
Acronym
MirDYS
Official Title
Epigenetic Regulation of Activity and Severity of Fibrous Dysplasia in Bone: mirDYS Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
February 10, 2025 (Anticipated)
Study Completion Date
February 10, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrous Dysplasia of Bone

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monostotic fibrous dysplasia
Arm Type
Experimental
Arm Description
Patients with monostotic Fibrous dysplasia.
Arm Title
Polyostotic fibrous dysplasia
Arm Type
Experimental
Arm Description
Patients with polyostotic Fibrous dysplasia.
Arm Title
Controls
Arm Type
Active Comparator
Arm Description
Control patients having a scheduled surgery for osteoarthritis.
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Description
A study specific blood sample will be collected.
Intervention Type
Other
Intervention Name(s)
Waste bone tissue
Intervention Description
For 3 patients of each group, patients having a scheduled surgery, a piece of waste bone tissue will be collected after surgery.
Primary Outcome Measure Information:
Title
Evaluation of micro Ribonucleic acids expression in the serum
Description
The objective is to identify specific microRibonucleic acids expressed in serum of patients using NGS (Next Generation Sequencing).
Time Frame
At inclusion
Title
Evaluation of micro Ribonucleic acids expression in the bone tissue
Description
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)
Time Frame
At inclusion
Secondary Outcome Measure Information:
Title
Comparison of micro Ribonucleic acids expression
Description
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).
Time Frame
Time of realization of the analyzes, an average of 6 months
Title
Validation of micro Ribonucleic acids identified by NGS (Next Generation Sequencing) in blood samples
Description
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.
Time Frame
Time of realization of the analyzes, an average of 6 months
Title
Association between micro Ribonucleic acids and severity of fibrous dysplasia.
Description
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).
Time Frame
Time of realization of the analyzes, an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: men and women, 18 years-old and over, with a diagnosis of fibrous dysplasia previously established by a rheumatologist. Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roland CHAPURLAT, Pr
Phone
04 72 11 74 81
Ext
+33
Email
roland.chapurlat@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Blandine MERLE, Ph.D
Phone
04 72 11 74 80
Ext
+33
Email
blandine.merle@inserm.fr
Facility Information:
Facility Name
Service de Rhumatologie & INSERM U1033, Pavillon F, Hopital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roland CHAPURLAT, Pr
Phone
04 72 11 74 81
Ext
+33
Email
roland.chapurlat@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Blandine MERLE, Ph.D
Phone
04 72 11 74 80
Ext
+33
Email
blandine.merle@inserm.fr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32526052
Citation
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.
Results Reference
derived

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Epigenetic Regulation in Fibrous Dysplasia of Bone: mirDYS Study.

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