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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024282-41 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | 8 mg/kg/month |
|
| Measure | Description | Time Frame |
|---|---|---|
| serum CTX (type 1 collagen C-terminal breakdown product) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bone pain | visual analog scale | 6 months |
| serum ICTP (Carboxyterminal Telopeptide of Type I Collagen) | 6 months | |
| Measure | Description | Time Frame |
|---|---|---|
| Biological safety | serum creatinine level, red blood cells, white blood cells, platelets, ASAT (Aspartate Amino Transferase), ALAT (Alanine Amino Transferase), CRP (C Reactive Protein) : each month cholesterol, triglycerides : before experimental treatment administration and at 8 weeks | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Rhumatologie, Groupe Hospitalier Pellegrin | Bordeaux | France | ||||
| Service de rhumatologie, Hopital Edouard Herriot, HCL |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35104665 | Result | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D005357 | Fibrous Dysplasia of Bone |
| D005359 | Fibrous Dysplasia, Polyostotic |
| ID | Term |
|---|---|
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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| Placebo | Drug |
|
| bone alkaline phosphatase |
| 6 months |
| radiographs of mostly affected area | 12 months |
| Lyon |
| 69003 |
| France |
| Service de rhumatologie, Hôpital Lariboisière | Paris | 75010 | France |