Interest of Serum Periostin Dosage in Patients With Bone Fibrous Dysplasia

Bone Fibrous Dysplasia Clinical Trial

— PERIOSTINE  

Official title:

Interest of Serum Periostin Dosage in Patients With Bone Fibrous Dysplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02868645
• Other study ID #: 69HCL15_0336
• Status: Completed
• Phase: N/A
• Start date: May 25, 2016
• Est. completion date: April 10, 2018

Study information

• Verified date: November 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 10, 2018
• Est. primary completion date: April 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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…)

Related Conditions & MeSH terms

• Bone Fibrous Dysplasia
• Fibrous Dysplasia of Bone

Intervention

Biological:
• Blood sampling
Patients with bone fibrous dysplasia will have blood sampling to assess periostin rate in serum

Locations

Country	Name	City	State
France	Service de rhumatologie Pavillon F - Hôpital Edouard Herriot	Lyon cedex 03

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Periostin rate in serum		At inclusion
Secondary	Periostin rate in serum according to the number of fibrotic bones		At inclusion
Secondary	Periostin rate in serum in patients with severe phenotype of the disease		At inclusion
Secondary	Periostin rate in serum in patients with Mac Cune Albright syndrome		At inclusion