NCT02868645

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2018

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

1.9 years

First QC Date

August 11, 2016

Last Update Submit

December 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Periostin rate in serum

    At inclusion

Secondary Outcomes (3)

  • Periostin rate in serum according to the number of fibrotic bones

    At inclusion

  • Periostin rate in serum in patients with severe phenotype of the disease

    At inclusion

  • Periostin rate in serum in patients with Mac Cune Albright syndrome

    At inclusion

Study Arms (2)

Patients with bone fibrous dysplasia

EXPERIMENTAL

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

Biological: Blood sampling

Control subjects

NO INTERVENTION

Control subjects will have no intervention

Interventions

Blood samplingBIOLOGICAL

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

Patients with bone fibrous dysplasia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de rhumatologie Pavillon F - Hôpital Edouard Herriot

Lyon, 69437, France

Location

Related Publications (1)

  • Guerin Lemaire H, Merle B, Borel O, Gensburger D, Chapurlat R. Serum periostin levels and severity of fibrous dysplasia of bone. Bone. 2019 Apr;121:68-71. doi: 10.1016/j.bone.2019.01.004. Epub 2019 Jan 4.

MeSH Terms

Conditions

Fibrous Dysplasia of Bone

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

OsteochondrodysplasiasBone Diseases, DevelopmentalBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2016

First Posted

August 16, 2016

Study Start

May 25, 2016

Primary Completion

April 10, 2018

Study Completion

April 10, 2018

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations