TOCILIZUMAB IN FIBROUS DYSPLASIA OF BONE

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01791842

Acronym

TOCIDYS

Enrollment

Registered

2013-02-15

Start date

2013-05-05

Completion date

2018-06-19

Last updated

2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibrous Dysplasia of Bone

Keywords

fibrous dysplasia of bone, tocilizumab, McCune-Albright syndrome

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.

Interventions

DRUGTocilizumab

8 mg/kg/month

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
serum CTX (type 1 collagen C-terminal breakdown product)	6 months

Secondary

Measure	Time frame	Description
bone alkaline phosphatase	6 months	—
radiographs of mostly affected area	12 months	—
Bone pain	6 months	visual analog scale
serum ICTP (Carboxyterminal Telopeptide of Type I Collagen)	6 months	—

Other

Measure	Time frame	Description
Biological safety	12 months	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026