Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 8
- 主要终点
- Intensity of bone pain, assessed by visual analogical scale ranging from 0 to 10, on the most painful site.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
1
treatment duration: 1 year
干预措施: risedronate (Drug)
2
treatment duration: 1 year
干预措施: placebo (Drug)
3
duration treatment: 3 years
干预措施: risedronate (Drug)
4
treatment duration: 3 years
干预措施: placebo (Drug)
结局指标
主要结局
Intensity of bone pain, assessed by visual analogical scale ranging from 0 to 10, on the most painful site.
时间窗: one year
Surface of osteolytic lesions at three years. Radiological improvement.
时间窗: Three years
次要结局
- Improvement in quality of life(one to three years)
- Variation in bone mineral density of the femoral neck at three years(three years)
- Number of painful sites(one year)
- Variation of biochemical markers of bone turnover at three years(three years)