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Interest of Serum Periostin Dosage in Patients With Bone Fibrous Dysplasia (PERIOSTINE)

Primary Purpose

Bone Fibrous Dysplasia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bone Fibrous Dysplasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients with fibrous dysplasia of the bone
  • access to social security
  • informed consent

Exclusion Criteria:

  • no informed consent
  • pregnancy
  • patients with a history of conditions known to increase periostin serum (stade IV cancer, severe asthma, pulmonary fibrosis…)

Sites / Locations

  • Service de rhumatologie Pavillon F - Hôpital Edouard Herriot

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patients with bone fibrous dysplasia

Control subjects

Arm Description

Patients with bone fibrous dysplasia will have a blood sampling to assess periostin rate in serum

Control subjects will have no intervention

Outcomes

Primary Outcome Measures

Periostin rate in serum

Secondary Outcome Measures

Periostin rate in serum according to the number of fibrotic bones
Periostin rate in serum in patients with severe phenotype of the disease
Periostin rate in serum in patients with Mac Cune Albright syndrome

Full Information

First Posted
August 11, 2016
Last Updated
November 5, 2018
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02868645
Brief Title
Interest of Serum Periostin Dosage in Patients With Bone Fibrous Dysplasia
Acronym
PERIOSTINE
Official Title
Interest of Serum Periostin Dosage in Patients With Bone Fibrous Dysplasia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
May 25, 2016 (Actual)
Primary Completion Date
April 10, 2018 (Actual)
Study Completion Date
April 10, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Fibrous dysplasia is a rare bone disease which can cause pain and fractures. It has been shown that periostin is over expressed in fibrous component in patients bones ; but periostin has never been measured out in serum of patients, although it is easy to assess. This study aims to show whether serum periostin is elevated in serum of patients with fibrous dysplasia, and if it is more elevated in patients with severe forms of the disease.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Patients with bone fibrous dysplasia
Arm Type
Experimental
Arm Description
Patients with bone fibrous dysplasia will have a blood sampling to assess periostin rate in serum
Arm Title
Control subjects
Arm Type
No Intervention
Arm Description
Control subjects will have no intervention
Intervention Type
Biological
Intervention Name(s)
Blood sampling
Intervention Description
Patients with bone fibrous dysplasia will have blood sampling to assess periostin rate in serum
Primary Outcome Measure Information:
Title
Periostin rate in serum
Time Frame
At inclusion
Secondary Outcome Measure Information:
Title
Periostin rate in serum according to the number of fibrotic bones
Time Frame
At inclusion
Title
Periostin rate in serum in patients with severe phenotype of the disease
Time Frame
At inclusion
Title
Periostin rate in serum in patients with Mac Cune Albright syndrome
Time Frame
At inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients with fibrous dysplasia of the bone access to social security informed consent Exclusion Criteria: no informed consent pregnancy patients with a history of conditions known to increase periostin serum (stade IV cancer, severe asthma, pulmonary fibrosis…)
Facility Information:
Facility Name
Service de rhumatologie Pavillon F - Hôpital Edouard Herriot
City
Lyon cedex 03
ZIP/Postal Code
69437
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Interest of Serum Periostin Dosage in Patients With Bone Fibrous Dysplasia

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