TOCILIZUMAB IN FIBROUS DYSPLASIA OF BONE

• Status: Completed
• Trial end date: 2018-06-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospices Civils de Lyon

Criteria

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