Epigenetic Regulation in Fibrous Dysplasia of Bone: mirDYS Study.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-10

Study Completion Date

2023-03-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Fibrous Dysplasia of Bone

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Monostotic fibrous dysplasia

Patients with monostotic Fibrous dysplasia.

Group Type EXPERIMENTAL

Blood sample

Intervention Type OTHER

A study specific blood sample will be collected.

Waste bone tissue

Intervention Type OTHER

For 3 patients of each group, patients having a scheduled surgery, a piece of waste bone tissue will be collected after surgery.

Polyostotic fibrous dysplasia

Patients with polyostotic Fibrous dysplasia.

Group Type EXPERIMENTAL

Blood sample

Intervention Type OTHER

A study specific blood sample will be collected.

Waste bone tissue

Intervention Type OTHER

For 3 patients of each group, patients having a scheduled surgery, a piece of waste bone tissue will be collected after surgery.

Controls

Control patients having a scheduled surgery for osteoarthritis.

Group Type ACTIVE_COMPARATOR

Blood sample

Intervention Type OTHER

A study specific blood sample will be collected.

Waste bone tissue

Intervention Type OTHER

For 3 patients of each group, patients having a scheduled surgery, a piece of waste bone tissue will be collected after surgery.

Interventions

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Blood sample

A study specific blood sample will be collected.

Intervention Type OTHER

Waste bone tissue

For 3 patients of each group, patients having a scheduled surgery, a piece of waste bone tissue will be collected after surgery.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No