EUCTR2006-003549-18-NL进行中（未招募）不适用
Reduction of Bone Morbidity Using an Oral Bisphosphonate in Fibrous Dysplasia of Bone - PROFIDYS
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ZonMw
- 入组人数
- 156
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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