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Completed

NCT Number: NCT01791842

TOCILIZUMAB IN FIBROUS DYSPLASIA OF BONE

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.

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Key information

Conditions

Fibrous Dysplasia Of Bone Bone Diseases Bone Diseases, Developmental Fibrous Dysplasia, Polyostotic Musculoskeletal Diseases Osteochondrodysplasias

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Service de Rhumatologie, Groupe Hospitalier Pellegrin, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tocilizumab

Drug

8 mg/kg/month

Placebo

Drug

Primary outcomes

  1. serum CTX (type 1 collagen C-terminal breakdown product)

    Time frame: 6 months

Secondary outcomes

  1. Bone pain

    Time frame: 6 months

    visual analog scale

  2. serum ICTP (Carboxyterminal Telopeptide of Type I Collagen)

    Time frame: 6 months

  3. bone alkaline phosphatase

    Time frame: 6 months

  4. radiographs of mostly affected area

    Time frame: 12 months

Other outcomes

  1. Biological safety

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: TOCIDYS

Important dates

Study start
2013
Primary completion
2015
Study completion
2018
First posted
Feb 15, 2013
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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