Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone

Fibrous Dysplasia of Bone Clinical Trial

— PROFIDYS  

Official title:

Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00445575
• Other study ID #: RBM 03-54
• Secondary ID: AFSSAPS 060834
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 22, 2007
• Est. completion date: December 7, 2017

Study information

• Verified date: August 2021
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 7, 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrous Dysplasia of Bone
• Hyperplasia

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint Luc	Brussels
France	Hopital E Herriot	Lyon
France	Hopital Cochin	Paris
France	Hopital Lariboisiere	Paris
Germany	Hospital Benjamin Franklin	Berlin
Germany	Cologne Clinical Centre	Cologne
Germany	Heildeberg Clinical Centre	Heidelberg
Netherlands	Leids Universitair Medisch Centrum	Leiden

Sponsors (4)

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

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of bone pain, assessed by visual analogical scale ranging from 0 to 10, on the most painful site.		one year
Primary	Surface of osteolytic lesions at three years. Radiological improvement.		Three years
Secondary	Variation of biochemical markers of bone turnover at three years		three years
Secondary	Number of painful sites		one year
Secondary	Improvement in quality of life		one to three years
Secondary	Variation in bone mineral density of the femoral neck at three years		three years

External Links

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