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| ID | Type | Description | Link |
|---|---|---|---|
| AFSSAPS 060834 |
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| Cliniques universitaires Saint-Luc- Université Catholique de Louvain | OTHER |
| Charite University, Berlin, Germany | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | treatment duration: 1 year |
|
| 2 | Placebo Comparator | treatment duration: 1 year |
|
| 3 | Experimental | duration treatment: 3 years |
|
| 4 | Placebo Comparator | treatment duration: 3 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires Saint Luc | Brussels | 1200 | Belgium | |||
| Hopital E Herriot |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D005357 | Fibrous Dysplasia of Bone |
| ID | Term |
|---|---|
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000068296 | Risedronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| 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. |
|
| 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. |
|
| 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. |
|
| one to three years |
| Variation in bone mineral density of the femoral neck at three years | three years |
| Lyon |
| 69437 |
| France |
| Hopital Lariboisiere | Paris | 75475 | France |
| Hopital Cochin | Paris | 75679 | France |
| Hospital Benjamin Franklin | Berlin | 12200 | Germany |
| Cologne Clinical Centre | Cologne | 50924 | Germany |
| Heildeberg Clinical Centre | Heidelberg | 69120 | Germany |
| Leids Universitair Medisch Centrum | Leiden | 2300 | Netherlands |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |