Clinical trial NCT00445575: Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone
Official title: Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Fibrous Dysplasia of Bone
Keywords: fibrous dysplasia of bone
Mac Cune Albright syndrome
bisphosphonates
risedronate
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Charite University, Berlin, Germany
First posted: 2007-03-09
Enrollment: 80
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Intensity of bone pain, assessed by visual analogical scale ranging from 0 to 10, on the most painful site.
timeFrame: one year
measure: Surface of osteolytic lesions at three years. Radiological improvement.
timeFrame: Three years
Secondary outcomes:
measure: Variation of biochemical markers of bone turnover at three years
timeFrame: three years
measure: Number of painful sites
timeFrame: one year
measure: Improvement in quality of life
timeFrame: one to three years
measure: Variation in bone mineral density of the femoral neck at three years
timeFrame: three years
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Lyon
country: France
facility: Hopital E Herriot
city: Paris
country: France
facility: Hopital Lariboisiere
city: Paris
country: France
facility: Hopital Cochin
city: Berlin
country: Germany
facility: Hospital Benjamin Franklin
city: Cologne
country: Germany
facility: Cologne Clinical Centre
city: Heidelberg
country: Germany
facility: Heildeberg Clinical Centre
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: ROLAND D CHAPURLAT, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL LARIBOISIERE
name: PHILIPPE ORCEL, MD PhD
role: STUDY_DIRECTOR
affiliation: Leiden University Medical Center
name: SOCRATES D PAPAPOULOS, MD PhD
role: STUDY_CHAIR
References: