Fibrous Dysplasia of BonePhase 2TOCIDYSNCT01791842
TOCILIZUMAB IN FIBROUS DYSPLASIA OF BONE
A Phase 2 study testing Tocilizumab in people with Fibrous Dysplasia of Bone, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
Bone pain due to fibrous dysplasia of bone is usually treated with bisphosphonates. A small proportion of patients fail to respond adequately. Mutated bone cells produce large amounts of Interleukin-6 (IL-6), with increased bone resorption as a result. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrous Dysplasia of Bone
- What is being tested?
- Tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 3 sitesFrance
- Study dates
- 5 May 2013to 19 Jun 2018
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- fibrous dysplasia of bone
- previously treated with IV bisphosphonates
- persistent bone pain and increased bone remodeling
Who cannot join
- Chronic renal failure
- serious infectious diseases
- liver enzymes abnormality
- pregnancy
- dyslipidemia
Trial locations and contacts
3 sites in 1 country.
France3 sites
Service de Rhumatologie, Groupe Hospitalier Pellegrin
Bordeaux
Service de rhumatologie, Hopital Edouard Herriot, HCL
Lyon, 69003
Service de rhumatologie, Hôpital Lariboisière
Paris, 75010
About this study
Official title: TREATMENT OF FIBROUS DYSPLASIA OF BONE WITH TOCILIZUMAB AMONG PATIENTS WHO DO NOT RESPOND TO BISPHOSPHONATES. THE TOCIDYS TRIAL.
Bone pain due to fibrous dysplasia of bone is usually treated with bisphosphonates. A small proportion of patients fail to respond adequately. Mutated bone cells produce large amounts of Interleukin-6 (IL-6), with increased bone resorption as a result. Inhibition of IL-6 may be of interest to reduce bone resorption and therefore bone pain. TOCIDYS is a placebo-controlled randomized cross-over trial to test the hypothesis that tocilizumab can reduce bone resorption in those patients with fibrous dysplasia who have already received bisphosphonates.
- Conditions
- Fibrous Dysplasia of Bone
- Being tested
- Tocilizumab, Placebo
- Keywords
- fibrous dysplasia of bone, tocilizumab, McCune-Albright syndrome
- Medical subject headings
- Fibrous Dysplasia of Bone, Fibrous Dysplasia, Polyostotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
8 mg/kg/month
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab first, then placebo | Experimental | one IV infusion per month of Tocilizumab for 6 months followed by 1 infusion per month of placebo, for 6 months. Receives: Drug: Tocilizumab; Drug: Placebo |
| Placebo first, then Tocilizumab | Experimental | one IV infusion per month of Placebo for 6 months followed by 1 infusion per month of Tocilizumab, for 6 months. Receives: Drug: Tocilizumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum CTX (type 1 collagen C-terminal breakdown product)
Measured: 6 months
Secondary outcomes (4)
Bone pain
visual analog scale
Measured: 6 months
serum ICTP (Carboxyterminal Telopeptide of Type I Collagen)
Measured: 6 months
bone alkaline phosphatase
Measured: 6 months
radiographs of mostly affected area
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study start5 May 2013
- Primary completionMay 2015
- Study completion19 Jun 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 Fibrous Dysplasia of BoneStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 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
- NCT01791842
- Sponsor's protocol ID
- 2010.648
- Other IDs
- 2010-024282-41
- Acronym
- TOCIDYS
- Status last verified
- Sep 2025
- First submitted
- 13 Feb 2013
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chapurlat R, Gensburger D, Trolliet C, Rouanet S, Mehsen-Cetre N, Orcel P. Inhibition of IL-6 in the treatment of fibrous dysplasia of bone: The randomized double-blind placebo-controlled TOCIDYS trial. Bone. 2022 Apr;157:116343. doi: 10.1016/j.bone.2022.116343. Epub 2022 Jan 29.
PubMed 35104665
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TREATMENT OF FIBROUS DYSPLASIA OF BONE WITH TOCILIZUMAB AMONG PATIENTS WHO DO NOT RESPOND TO BISPHOSPHONATES. THE TOCIDYS TRIAL.
- ClinicalTrials.gov ID
- NCT01791842
- Acronym / sponsor ID
- TOCIDYS / 2010.648
- Conditions
- Fibrous Dysplasia of Bone
- Keywords
- fibrous dysplasia of bone, tocilizumab, McCune-Albright syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 5 May 2013 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- 19 Jun 2018 (actual)
- First posted
- 15 Feb 2013 (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.
Bone pain due to fibrous dysplasia of bone is usually treated with bisphosphonates. A small proportion of patients fail to respond adequately. Mutated bone cells produce large amounts of Interleukin-6 (IL-6), with increased bone resorption as a result. Inhibition of IL-6 may be of interest to reduce bone resorption and therefore bone pain. TOCIDYS is a placebo-controlled randomized cross-over trial to test the hypothesis that tocilizumab can reduce bone resorption in those patients with fibrous dysplasia who have already received bisphosphonates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab first, then placebo | Experimental | Drug: Tocilizumab, Drug: Placeboone IV infusion per month of Tocilizumab for 6 months followed by 1 infusion per month of placebo, for 6 months. |
| Placebo first, then Tocilizumab | Experimental | Drug: Tocilizumab, Drug: Placeboone IV infusion per month of Placebo for 6 months followed by 1 infusion per month of Tocilizumab, for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- fibrous dysplasia of bone
- previously treated with IV bisphosphonates
- persistent bone pain and increased bone remodeling
Key exclusion criteria (5 listed)
- Chronic renal failure
- serious infectious diseases
- liver enzymes abnormality
- pregnancy
- dyslipidemia
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 |
|---|---|---|
| Tocilizumab8 mg/kg/month | Drug | Placebo first, then Tocilizumab, Tocilizumab first, then placebo |
| Placebo | Drug | Placebo first, then Tocilizumab, Tocilizumab first, then placebo |
Primary outcome
serum CTX (type 1 collagen C-terminal breakdown product)
Time frame: 6 months
4 secondary outcomes
Bone pain
Time frame: 6 months
serum ICTP (Carboxyterminal Telopeptide of Type I Collagen)
Time frame: 6 months
bone alkaline phosphatase
Time frame: 6 months
radiographs of mostly affected area
Time frame: 12 months
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 2 Oct 2025.
- Results publication: PubMed 35104665Chapurlat R, Gensburger D, Trolliet C, Rouanet S, Mehsen-Cetre N, Orcel P. Inhibition of IL-6 in the treatment of fibrous dysplasia of bone: The randomized double-blind placebo-controlled TOCIDYS trial. Bone. 2022 Apr;157:116343. doi: 10.1016/j.bone.2022.116343. Epub 2022 Jan 29.
- Related InfoLink provided by the sponsor.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tocilizumab in people with Fibrous Dysplasia of Bone, run by Hospices Civils de Lyon at 3 sites 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 5 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 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
serum CTX (type 1 collagen C-terminal breakdown product) (time frame: 6 months). 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 NCT01791842, 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 2 Oct 2025.