EUCTR2009-017649-67-IE进行中（未招募）不适用
Bone Health in Duchenne Muscular Dystrophy- a case controlled study of Risedronate use - Risedronate in DMD
The Central Remedial Clinic and The Children's University Hospital0 个研究点目标入组 70 人开始时间: 2010年1月13日最近更新:
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
- 入组人数
- 70
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
- Male
入选标准
- •1.>/4 years old at time of initiation of study
- •2. Z score as measured by DXA >1.0 S.D. below the mean
- •3. boys only with DMD
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Hypersensitivity to Risedronate sodium
- •2. <4years at time of initiation of study
- •3. Previous bisphosphonate use
- •4. Uncorrected hypocalcaemia, uncorrected low Vitamin D
- •5. Inability to stay in an upright position (sitting or standing) for at least 30minutes
- •6. Severe renal impairment (creatinine clearance <30ml/min)
- •7.Undergoing invasive dental treatment
- •8. History of recent or active oesophageal or upper gastrointestinal problems
- •9.History of oesophageal disorders which delay oesophageal transit or emptying e.g. stricture or achalasia
- •10. Involvement in clinical trial in the preceding 12 weeks.
- •11. Learning difficulties in carer resulting in difficulties comprehending treatment
研究者
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