Bone Fibrous DysplasiaPERIOSTINENCT02868645
Interest of Serum Periostin Dosage in Patients With Bone Fibrous Dysplasia
A study testing Blood sampling in people with Bone Fibrous Dysplasia, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Fibrous Dysplasia
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 25 May 2016to 10 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with fibrous dysplasia of the bone
- access to social security
- informed consent
Who cannot join
- no informed consent
- pregnancy
- patients with a history of conditions known to increase periostin serum (stade IV cancer, severe asthma, pulmonary fibrosis…)
Trial locations and contacts
1 site in 1 country.
France1 site
Service de rhumatologie Pavillon F - Hôpital Edouard Herriot
Lyon, 69437
About this study
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.
- Conditions
- Bone Fibrous Dysplasia
- Being tested
- Blood sampling
- Medical subject headings
- Fibrous Dysplasia of Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
Patients with bone fibrous dysplasia will have blood sampling to assess periostin rate in serum
| Study group | Role | What they receive |
|---|---|---|
| Patients with bone fibrous dysplasia | Experimental | Patients with bone fibrous dysplasia will have a blood sampling to assess periostin rate in serum Receives: Biological: Blood sampling |
| Control subjects | No intervention | Control subjects will have no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periostin rate in serum
Measured: At inclusion
Secondary outcomes (3)
Periostin rate in serum according to the number of fibrotic bones
Measured: At inclusion
Periostin rate in serum in patients with severe phenotype of the disease
Measured: At inclusion
Periostin rate in serum in patients with Mac Cune Albright syndrome
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study start25 May 2016
- Primary completion10 Apr 2018
- Study completion10 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone Fibrous DysplasiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868645
- Sponsor's protocol ID
- 69HCL15_0336
- Acronym
- PERIOSTINE
- Status last verified
- Dec 2025
- First submitted
- 11 Aug 2016
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30616028
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Serum Periostin Dosage in Patients With Bone Fibrous Dysplasia
- ClinicalTrials.gov ID
- NCT02868645
- Acronym / sponsor ID
- PERIOSTINE / 69HCL15_0336
- Conditions
- Bone Fibrous Dysplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 25 May 2016 (actual)
- Primary completion
- 10 Apr 2018 (actual)
- Study completion
- 10 Apr 2018 (actual)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with bone fibrous dysplasia | Experimental | Biological: Blood samplingPatients with bone fibrous dysplasia will have a blood sampling to assess periostin rate in serum |
| Control subjects | No intervention | –Control subjects will have no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with fibrous dysplasia of the bone
- access to social security
- informed consent
Key exclusion criteria (3 listed)
- no informed consent
- pregnancy
- patients with a history of conditions known to increase periostin serum (stade IV cancer, severe asthma, pulmonary fibrosis…)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingPatients with bone fibrous dysplasia will have blood sampling to assess periostin rate in serum | Biological | Patients with bone fibrous dysplasia |
Primary outcome
Periostin rate in serum
Time frame: At inclusion
3 secondary outcomes
Periostin rate in serum according to the number of fibrotic bones
Time frame: At inclusion
Periostin rate in serum in patients with severe phenotype of the disease
Time frame: At inclusion
Periostin rate in serum in patients with Mac Cune Albright syndrome
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 30616028Guerin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Bone Fibrous Dysplasia, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periostin rate in serum (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02868645, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.