Fibrous Dysplasia of Bone
Conditions
Keywords
fibrous dysplasia of bone, Mac Cune Albright syndrome, bisphosphonates, risedronate
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.
Interventions
DRUGrisedronate
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.
DRUGplacebo
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.
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Charite University, Berlin, Germany
Institut National de la Santé Et de la Recherche Médicale, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Belgium, France, Germany, Netherlands
Outcome results
None listed