Trials / Completed
CompletedNCT01791842
TOCILIZUMAB IN FIBROUS DYSPLASIA OF BONE
TREATMENT OF FIBROUS DYSPLASIA OF BONE WITH TOCILIZUMAB AMONG PATIENTS WHO DO NOT RESPOND TO BISPHOSPHONATES. THE TOCIDYS TRIAL.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Hospices Civils de Lyon · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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. 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tocilizumab | 8 mg/kg/month |
| DRUG | Placebo |
Timeline
- Start date
- 2013-05-05
- Primary completion
- 2015-05-01
- Completion
- 2018-06-19
- First posted
- 2013-02-15
- Last updated
- 2025-10-02
Locations
3 sites across 1 country: France
Source: ClinicalTrials.gov record NCT01791842. Inclusion in this directory is not an endorsement.