Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone

NCT00445575 | Completed Phase 2 DMC

• 2 other identifiers: RBM 03-54AFSSAPS 060834
• Study Type: interventional
• Target: 80
• Locations: 4 countries
• Sites: 8

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.

Conditions

Fibrous Dysplasia of Bone

Keywords

fibrous dysplasia of bone; Mac Cune Albright syndrome; bisphosphonates; risedronate

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Variation of biochemical markers of bone turnover at three years

  three years

• Number of painful sites

  one year

• Improvement in quality of life

  one to three years

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

  three years

Study Arms (4)

1

EXPERIMENTAL

treatment duration: 1 year

Drug: risedronate

2

PLACEBO COMPARATOR

treatment duration: 1 year

Drug: placebo

3

EXPERIMENTAL

duration treatment: 3 years

Drug: risedronate

4

PLACEBO COMPARATOR

treatment duration: 3 years

Drug: placebo

Interventions

risedronate 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.

1

placebo 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.

2

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: collaborator
• Charite University, Berlin, Germany: collaborator

Study Sites (8)

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

Hopital E Herriot

Lyon, 69437, France

Location

Hopital Lariboisiere

Paris, 75475, France

Location

Hopital Cochin

Paris, 75679, France

Location

Hospital Benjamin Franklin

Berlin, 12200, Germany

Location

Cologne Clinical Centre

Cologne, 50924, Germany

Location

Heildeberg Clinical Centre

Heidelberg, 69120, Germany

Location

Leids Universitair Medisch Centrum

Leiden, 2300, Netherlands

Location

Related Links

• Related Info

MeSH Terms

Conditions

Fibrous Dysplasia of Bone

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• ROLAND D CHAPURLAT, MD PhD

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

  PRINCIPAL INVESTIGATOR

• PHILIPPE ORCEL, MD PhD

  HOPITAL LARIBOISIERE

  STUDY DIRECTOR

• SOCRATES D PAPAPOULOS, MD PhD

  Leiden University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2007
• First Posted: March 9, 2007
• Study Start: July 22, 2007
• Primary Completion: December 1, 2017
• Study Completion: December 7, 2017
• Last Updated: August 30, 2021

Record last verified: 2021-08

Locations

BE (1); FR (3); DE (3); NL (1)