Clinical Trial: TOCILIZUMAB IN FIBROUS DYSPLASIA OF BONE
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: TREATMENT OF FIBROUS DYSPLASIA OF BONE WITH TOCILIZUMAB AMONG PATIENTS WHO DO NOT RESPOND TO BISPHOSPHONATES. THE TOCIDYS TRIAL.
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.
Detailed Summary:
Sponsor: Hospices Civils de Lyon
Current Primary Outcome: serum CTX (type 1 collagen C-terminal breakdown product) [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Bone pain [ Time Frame: 6 months ]visual analog scale
- 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 ]
Original Secondary Outcome: Same as current
Information By: Hospices Civils de Lyon
Dates:
Date Received: February 13, 2013
Date Started: February 2013
Date Completion: May 2015
Last Updated: March 14, 2013
Last Verified: March 2013
