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ClinicalTrials.gov Identifier: NCT01791842
Recruitment Status : Unknown
Verified March 2013 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : February 15, 2013
Last Update Posted : March 15, 2013
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Fibrous Dysplasia of Bone Drug: Tocilizumab Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2013
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

Arms and Interventions

Arm Intervention/treatment
Experimental: Tocilizumab first, then placebo
one IV infusion per month of Tocilizumab for 6 months followed by 1 infusion per month of placebo, for 6 months.
Drug: Tocilizumab
8 mg/kg/month
Drug: Placebo
Experimental: Placebo first, then Tocilizumab
one IV infusion per month of Placebo for 6 months followed by 1 infusion per month of Tocilizumab, for 6 months.
Drug: Tocilizumab
8 mg/kg/month
Drug: Placebo

Outcome Measures

Primary Outcome Measures :
  1. serum CTX (type 1 collagen C-terminal breakdown product) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Bone pain [ Time Frame: 6 months ]
    visual analog scale

  2. serum ICTP (Carboxyterminal Telopeptide of Type I Collagen) [ Time Frame: 6 months ]
  3. bone alkaline phosphatase [ Time Frame: 6 months ]
  4. radiographs of mostly affected area [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Biological safety [ Time Frame: 12 months ]
    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

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • fibrous dysplasia of bone
  • previously treated with IV bisphosphonates
  • persistent bone pain and increased bone remodeling

Exclusion Criteria:

  • Chronic renal failure
  • serious infectious diseases
  • liver enzymes abnormality
  • pregnancy
  • dyslipidemia
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01791842

Contact: Roland CHAPURLAT, Professor +33472117481 roland.chapurlat@inserm.fr
Contact: Deborah GENSBURGER, Dr +33472119702 deborah.gensburger@chu-lyon.fr

Hopital Edouard Herriot - service de rhumatologie Recruiting
Lyon, France, 69003
Contact: Roland Chapurlat, Professor    +33472117481      
Principal Investigator: Roland CHAPURLAT, Professor         
Sub-Investigator: Deborah GENSBURGER, Dr         
Hôpital Lariboisière - service de rhumatologie Not yet recruiting
Paris, France, 75010
Contact: Philippe ORCEL, Professor         
Principal Investigator: Philippe ORCEL, Professor         
Sponsors and Collaborators
Hospices Civils de Lyon
More Information

Additional Information:
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01791842     History of Changes
Other Study ID Numbers: 2010.648
2010-024282-41 ( EudraCT Number )
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: March 15, 2013
Last Verified: March 2013

Keywords provided by Hospices Civils de Lyon:
fibrous dysplasia of bone
McCune-Albright syndrome

Additional relevant MeSH terms:
Fibrous Dysplasia of Bone
Pathologic Processes
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases