Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone (PROFIDYS)

Institut National de la Santé Et de la Recherche Médicale, France

Status and phase: Completed; Phase 3; Phase 2

Conditions: Fibrous Dysplasia of Bone

Treatments: Drug: risedronate; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00445575

AFSSAPS 060834

RBM 03-54

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

treatment duration: 1 year

Treatment:

Drug: risedronate

Drug: risedronate

2

Placebo Comparator group

Description:

treatment duration: 1 year

Treatment:

Drug: placebo

Drug: placebo

3

Experimental group

Description:

duration treatment: 3 years

Treatment:

Drug: risedronate

Drug: risedronate

4

Placebo Comparator group

Description:

treatment duration: 3 years

Treatment:

Drug: placebo

Drug: placebo