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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
19
8 mg/kg/month
Service de Rhumatologie, Groupe Hospitalier Pellegrin
Bordeaux, France
Service de rhumatologie, Hopital Edouard Herriot, HCL
Lyon, France
Service de rhumatologie, Hôpital Lariboisière
Paris, France
serum CTX (type 1 collagen C-terminal breakdown product)
Time frame: 6 months
Bone pain
visual analog scale
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
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