TOCILIZUMAB IN FIBROUS DYSPLASIA OF BONE

Fibrous Dysplasia of Bone Clinical Trial

— TOCIDYS  

Official title:

TREATMENT OF FIBROUS DYSPLASIA OF BONE WITH TOCILIZUMAB AMONG PATIENTS WHO DO NOT RESPOND TO BISPHOSPHONATES. THE TOCIDYS TRIAL.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791842
• Other study ID #: 2010.648
• Secondary ID: 2010-024282-41
• Status: Completed
• Phase: Phase 2
• Start date: May 5, 2013
• Est. completion date: June 19, 2018

Study information

• Verified date: March 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 19, 2018
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrous Dysplasia of Bone
• Hyperplasia

Intervention

Drug:
• Tocilizumab
8 mg/kg/month
• Placebo

Locations

Country	Name	City	State
France	Service de Rhumatologie, Groupe Hospitalier Pellegrin	Bordeaux
France	Service de rhumatologie, Hopital Edouard Herriot, HCL	Lyon
France	Service de rhumatologie, Hôpital Lariboisière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biological safety	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	12 months
Primary	serum CTX (type 1 collagen C-terminal breakdown product)		6 months
Secondary	Bone pain	visual analog scale	6 months
Secondary	serum ICTP (Carboxyterminal Telopeptide of Type I Collagen)		6 months
Secondary	bone alkaline phosphatase		6 months
Secondary	radiographs of mostly affected area		12 months

External Links

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