TOCILIZUMAB IN FIBROUS DYSPLASIA OF BONE
Information source: Hospices Civils de Lyon
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fibrous Dysplasia of Bone
Intervention: Tocilizumab (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Hospices Civils de Lyon Overall contact: Roland CHAPURLAT, Professor, Phone: +33472117481, Email: roland.chapurlat@inserm.fr
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.
Clinical Details
Official title: TREATMENT OF FIBROUS DYSPLASIA OF BONE WITH TOCILIZUMAB AMONG PATIENTS WHO DO NOT RESPOND TO BISPHOSPHONATES. THE TOCIDYS TRIAL.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: serum CTX (type 1 collagen C-terminal breakdown product)
Secondary outcome: Bone painserum ICTP (Carboxyterminal Telopeptide of Type I Collagen) bone alkaline phosphatase radiographs of mostly affected area
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Roland CHAPURLAT, Professor, Phone: +33472117481, Email: roland.chapurlat@inserm.fr
Hopital Edouard Herriot - service de rhumatologie, Lyon 69003, France; Recruiting Roland Chapurlat, Professor, Phone: +33472117481 Roland CHAPURLAT, Professor, Principal Investigator Deborah GENSBURGER, Dr, Sub-Investigator
Hôpital Lariboisière - service de rhumatologie, Paris 75010, France; Not yet recruiting Philippe ORCEL, Professor Philippe ORCEL, Professor, Principal Investigator
Additional Information
Starting date: February 2013
Last updated: March 14, 2013
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