Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone

Institut National de la Santé Et de la Recherche Médicale, France80 enrolled

Overview

This trial is intended to test the efficacy of an oral bisphosphonate (risedronate) to decrease bone pain and improve radiological aspect in fibrous dysplasia of bone.

In open pilot studies, it has been suggested that bisphosphonates may alleviate bone pain and help decrease the surface of osteolytic lesion in patients with fibrous dysplasia of bone (FD). So, in this randomized placebo controlled trial, we test the hypothesis that the bisphosphonate risedronate reduces bone pain in patients with FD (study I, one year duration) and decrease osteolytic lesions (study II, three years duration). Patients will take risedronate during 2 months courses, every 6 months or a matching placebo. Dosage will be : 30mg tablet/day for adults and 5mg tablet x 2,4 according to the age and weight of the child. All participants will receive calcium and vitamin D. All patients with renal phosphate wasting will receive an oral phosphate supplement.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Fibrous Dysplasia of Bone

Interventions

risedronateDRUG

During two months courses, every 6 months : 30mg tablet/day for adults and 10mg/day or 20mg/day for children, according to the age and weight of the child.

placeboDRUG

placebo and risedronate have exactly the same aspect. During two months courses, every 6 months : 30mg tablet/day for adults and 10mg/day or 20mg/day for children, according to the age and weight of the child.

risedronateDRUG

During two months courses, every 6 months : 30mg tablet/day for adults and 10mg/day or 20mg/day for children, according to the age and weight of the child.

Eligibility

Sex: ALLMin age: 8 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Study I: patients with FD, with bone pain intensity above 3 on visual analogical scale from 0 to 10 * Study II: patients with FD with at least one osteolytic lesion and no current bone pain Exclusion Criteria: * patients \< 8 years old * other diseases affecting bone metabolism * patients with malignant diseases or other conditions likely to reduce their life expectancy to less than 3 years * patients with history of significant upper gastrointestinal disorders * renal failure (creatinine clearance \< 25 ml/mn) * severe liver disease * history of iritis or uveitis * rickets or osteomalacia * allergy to bisphosphonates * pregnancy or lactation * prior treatment with a bisphosphonate * laboratory abnormalities that may be considered as clinically significant by trial physicians

Locations (8)

Cliniques Universitaires Saint Luc

Brussels, Belgium

Hopital E Herriot

Lyon, France

Hopital Lariboisiere

Paris, France

Hopital Cochin

Paris, France

Outcomes

Primary Outcomes

Intensity of bone pain, assessed by visual analogical scale ranging from 0 to 10, on the most painful site.

Time frame: one year

Surface of osteolytic lesions at three years. Radiological improvement.

Time frame: Three years

Secondary Outcomes

Variation of biochemical markers of bone turnover at three years

Time frame: three years

Number of painful sites

Time frame: one year

Improvement in quality of life

Time frame: one to three years

Variation in bone mineral density of the femoral neck at three years

Time frame: three years

Data from ClinicalTrials.gov

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