Fibrous Dysplasia of Bone, MedDRA 8.0, 10016664
Conditions
Interventions
Trade Name: Actonel 30 mg
Pharmaceutical Form: Coated tablet
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
Sponsors
ZonMw
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Study I: Patients with fibrous dysplasia with painful lesions of intensity above 3 on a visual scale analog from 0 to 10. Study II: Patients with fibrous dysplasia of bone with at least one osteolytic lesion and no current bone pain. Are the trial subjects under 18? no 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: patients yournger than 8 years patients with other diseases or receiving treatments likely to affect bone metabolism patients with significant upper gastrointestinal disorders renal insufficiency (creatinine clearance <25 ml/min) liver disease in both studies estrogen replacement therapy will be allowed women at child bearing age should have a negative pregnancy test and be willing to use a medically acceptable method of contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Define the efficacy of a bisphosphonate, risedronate (associated with calcium and vitamin D supplementation, or to calcium, oral phosphate, and calcitriol supplementation) to reduce bone pain in patients with fibrous dysplasia of bone. Define the effect of risedronate in the prevention of the evolution of osteolytic lesions in patients with fibrous dysplasia of bone.;Secondary Objective: Define the safety and tolerability of the bisphosphonate risedronate (associated with calcium and vitamin D, and to oral phosphate in patients who have renal phosphate wasting) in patients with fibrous dysplasia of bone. Examine the effect of risedronate to improve quality of life in patients with fibrous dysplasia of bone.;Primary end point(s): Study I: Reduction in bone pain assessed by a visual analog scale; reduction of the number of painful bone sites, decrease in the use of analgesics. Improvement of the quality of life, reduction in biochemical markers of bone metabolism, radiological improvement and increase in bone mineral density. Study II: Radiological improvement of lytic bone lesions, assessed quantitatively | — |
Countries
Netherlands
Outcome results
None listed