Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone

NCT ID: NCT00445575

Last Updated: 2021-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-22
• Study Completion Date: 2017-12-07

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.

Conditions

Fibrous Dysplasia of Bone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

treatment duration: 1 year

Group Type: EXPERIMENTAL

risedronate

Intervention Type: DRUG

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.

2

treatment duration: 1 year

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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.

3

duration treatment: 3 years

Group Type: EXPERIMENTAL

risedronate

Intervention Type: DRUG

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.

4

treatment duration: 3 years

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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.

Interventions

risedronate

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.

Intervention Type: DRUG

placebo

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.

Intervention Type: DRUG

risedronate

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.

Intervention Type: DRUG

placebo

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ROLAND D CHAPURLAT, MD PhD

Role: PRINCIPAL_INVESTIGATOR

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

PHILIPPE ORCEL, MD PhD

Role: STUDY_DIRECTOR

HOPITAL LARIBOISIERE

SOCRATES D PAPAPOULOS, MD PhD

Role: STUDY_CHAIR

Leiden University Medical Center

Locations

Cliniques Universitaires Saint Luc

Brussels, , Belgium

Hopital E Herriot

Lyon, , France

Hopital Lariboisiere

Paris, , France

Hopital Cochin

Paris, , France

Hospital Benjamin Franklin

Berlin, , Germany

Cologne Clinical Centre

Cologne, , Germany

Heildeberg Clinical Centre

Heidelberg, , Germany

Leids Universitair Medisch Centrum

Leiden, , Netherlands

Countries

Belgium; France; Germany; Netherlands

Related Links

http://www.dysplasie-fibreuse-des-os.info/fr/accueil.html

Related Info

Other Identifiers

AFSSAPS 060834

Identifier Type: -

Identifier Source: secondary_id

RBM 03-54

Identifier Type: -

Identifier Source: org_study_id