Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone

Phase 2

Completed

• Conditions: Fibrous Dysplasia of Bone
• Interventions: Drug: placebo; Drug: risedronate

• Registration Number: NCT00445575
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2007-03-08
• Study First Submitted QC: 2007-03-08
• Study First Posted: 2007-03-09
• Study Start: 2007-07-22
• Primary Completion: 2017-12
• Study Completion: 2017-12-07
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-27
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	treatment duration: 1 year
4	placebo	treatment duration: 3 years
1	risedronate	treatment duration: 1 year
3	risedronate	duration treatment: 3 years

Primary Outcome Measures

Name	Time	Method
Intensity of bone pain, assessed by visual analogical scale ranging from 0 to 10, on the most painful site.	one year
Surface of osteolytic lesions at three years. Radiological improvement.	Three years

Secondary Outcome Measures

Name	Time	Method
Improvement in quality of life	one to three years
Variation in bone mineral density of the femoral neck at three years	three years
Number of painful sites	one year
Variation of biochemical markers of bone turnover at three years	three years

Trial Locations

Locations (8)

Cliniques Universitaires Saint Luc; 🇧🇪 Brussels, Belgium

Leids Universitair Medisch Centrum; 🇳🇱 Leiden, Netherlands

Hopital E Herriot; 🇫🇷 Lyon, France

Hopital Lariboisiere; 🇫🇷 Paris, France

Hopital Cochin; 🇫🇷 Paris, France

Hospital Benjamin Franklin; 🇩🇪 Berlin, Germany

Heildeberg Clinical Centre; 🇩🇪 Heidelberg, Germany

Cologne Clinical Centre; 🇩🇪 Cologne, Germany