Fibrous dysplasia •Study I: patients with fibrous dysplasia of bone, with bone pain intensity above 3 on a visual analogical scale from 0 to 10. •Study II: patients with fibrous dysplasia of bone, with at least one osteolytic lesion and no current bone pain. MedDRA version: 9.1 Level: PT Classification code 10016664 Term: Fibrous dysplasia of bone
Conditions
Interventions
Trade Name: Actonel
Product Name: ACTONEL 30mg
Product Code: NE- 58095
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral u
Sponsors
Cliniques Universitaires SAINT-LUC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Study I: patients with fibrous dysplasia of bone, with bone pain intensity above 3 on a visual analogical scale from 0 to 10. · Study II: patients with fibrous dysplasia of bone, with at least one osteolytic lesion and no current bone pain. Diagnosis of fibrous dysplasia will be asserted by a clinical expert (one of the clinical investigators), on clinical, radiographic and possibly histologic data. A radionuclide bone scan will be performed in each screened patient in order to identify every skeletal dysplastic lesions. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: For both study I and II, the following exclusion criteria will apply: - patients < 8 years old (no adequate experience in the use of BP before this age) - patients with other diseases or taking other treatments likely to affect bone metabolism - patients with malignant diseases or conditions likely to reduce their life expectancy to less than three years - patients with a history of significant upper gastrointestinal disorders (e.g. oesophagitis and gastroduodenal ulcer), which can interfere with compliance - kidney failure (creatinin clearance < 25 ml/mn) - severe liver disease that would affect alkaline phosphatase levels, such as hepatitis, primary biliary sclerosis, and cirrhosis - history of iritis or uveitis - untreated rickets or osteomalacia - allergy to BP - prior use of bisphosphonates, fluoride - pregnancy and lactation - laboratory abnormalities that may be considered as clinically significant by trial physicians · In both studies, oestrogen replacement therapy will be allowed, and also prior use of calcitonin after a 3 months wash out period. · Women with childbearing potential must have a negative serum b-HCG pregnancy test, and they must be willing to practice a medically acceptable form of birth control during the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) Efficacity of the biphosphonate risedronate (associated to calcium and vitamin D, or to calcium, oral phosphate, and calcitriol in patients who have renal phosphonate wasting) to improve bone pain in patients with fibrous dysplasia of bone. 2) Efficacity of the biphosphonate risedronate (associated to calcium and vitamin D, and to oral phosphonate in patients who have renal phosphate wasting) to improve osteolytic lesions in patients with fibrous dysplasia of bone.;Secondary Objective: 1) Safety and tolerability of the biphosphonate risedronate (associated to calcium and vitamin D, or to calcium, oral phosphate, and calcitriol in patients who have renal phosphonate wasting) in patients with fibrous dysplasia of bone. 2) Efficacity of the biphosphonate risedronate (associated to calcium and vitamin D, or to calcium, oral phosphate, and calcitriol in patients who have renal phosphonate wasting) to improve quality of life in patients with fibrous dysplasia of bone;Primary end point(s): - Study I : Intensity of bone pain assessed by a visual analogical scale [VAL] ranging from 0 to 10 on the most painful site - Study II: Radiological improvement | — |
Countries
Belgium, Netherlands
Outcome results
None listed