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

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Completed
• CT.gov ID: NCT02868645
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Arms: 2
• Actual Duration (Months): 22.5
• Patients Per Site Per Month: 2.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Fibrous Dysplasia	Biological: Blood sampling	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Interest of Serum Periostin Dosage in Patients With Bone Fibrous Dysplasia
• Actual Study Start Date: May 25, 2016
• Actual Primary Completion Date: Apr 10, 2018
• Actual Study Completion Date: Apr 10, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Periostin rate in serum [At inclusion]

Secondary Outcome Measures

1. Periostin rate in serum according to the number of fibrotic bones [At inclusion]

2. Periostin rate in serum in patients with severe phenotype of the disease [At inclusion]

3. Periostin rate in serum in patients with Mac Cune Albright syndrome [At inclusion]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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…)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service de rhumatologie Pavillon F - Hôpital Edouard Herriot	Lyon cedex 03		France	69437

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT02868645
• Other Study ID Numbers: 69HCL15_0336
• First Posted: Aug 16, 2016
• Last Update Posted: Nov 7, 2018
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Fibrous Dysplasia of Bone

Study Results

No Results Posted as of Nov 7, 2018