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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 pain

serum 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

Page last updated: August 23, 2015

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