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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.
Details
| Lead sponsor | Hospices Civils de Lyon |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 19 |
| Start date | 2013-05-05 |
| Completion | 2018-06-19 |
Conditions
- Fibrous Dysplasia of Bone
Interventions
- Tocilizumab
- Placebo
Primary outcomes
- serum CTX (type 1 collagen C-terminal breakdown product) — 6 months
Countries
France