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

November 5, 2018 updated by: Hospices Civils de Lyon
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon cedex 03, France, 69437
        • Service de rhumatologie Pavillon F - Hôpital Edouard Herriot

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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…)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with bone fibrous dysplasia
Patients with bone fibrous dysplasia will have a blood sampling to assess periostin rate in serum
Biological: Blood sampling
Patients with bone fibrous dysplasia will have blood sampling to assess periostin rate in serum
No Intervention: Control subjects
Control subjects will have no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Periostin rate in serum
Time Frame: At inclusion
At inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Periostin rate in serum according to the number of fibrotic bones
Time Frame: At inclusion
At inclusion
Periostin rate in serum in patients with severe phenotype of the disease
Time Frame: At inclusion
At inclusion
Periostin rate in serum in patients with Mac Cune Albright syndrome
Time Frame: At inclusion
At inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2016

Primary Completion (Actual)

April 10, 2018

Study Completion (Actual)

April 10, 2018

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

August 11, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Actual)

November 7, 2018

Last Update Submitted That Met QC Criteria

November 5, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL15_0336

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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