TOCILIZUMAB IN FIBROUS DYSPLASIA OF BONE
- Sponsor
- Hospices Civils de Lyon
- Study ID
- NCT01791842
- Phase
- PHASE2
- Status
- Completed
Conditions
- Fibrous Dysplasia of Bone
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Tocilizumab — DRUG8 mg/kg/month
- Placebo — DRUG
Study Details
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.
Key Dates
- Start date
- May 5, 2013
- Status verified
- Sep 2025
- Primary completion
- May 31, 2015
- Completion
- Jun 19, 2018
Study Design
- Enrollment
- 19 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: Tocilizumab first, then placeboone IV infusion per month of Tocilizumab for 6 months followed by 1 infusion per month of placebo, for 6 months.
- Experimental: Placebo first, then Tocilizumabone IV infusion per month of Placebo for 6 months followed by 1 infusion per month of Tocilizumab, for 6 months.
Primary Outcome Measure
serum CTX (type 1 collagen C-terminal breakdown product) [ Time Frame: 6 months ]