NCT00446589终止4 期
The Effects of Ibandronate or Teriparatide Therapy on Bone Histology and Biochemical Indices in Patients on Hemodialysis With Low Bone Mineral Density
Papageorgiou General Hospital1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2006年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Effects of ibandronate and teriparatide on bone mineral density and bone histology in HD patients.
研究概览
简要总结
Hemodialysis patients with low bone density (total hip T-score <-2.5) will be assigned to receive teriparatide (those with histologic confirmation of adynamic bone disease) or ibandronate (subjects with increased osteoclast number on bone biopsy).
Follow-up period: one year. A second bone biopsy at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bone mineral density (T-score<-2.5)
- •Adynamic bone disease for the teriparatide group
- •Increased osteoclast number on bone biopsy (high turnover) for the ibandronate group
- •Calcium greater than 8.1 mg/dl
排除标准
- •Suspected carcinoma
- •Unstable clinical setting
研究组 & 干预措施
F
Experimental
HD pts suffering from osteoporosis and adynamic bone disease who received teriparatide
干预措施: teriparatide (Drug)
I
Experimental
Hemodialysis pts suffering from osteoporosis who received iv ibandronate
干预措施: ibandronate (Drug)
结局指标
主要结局
Effects of ibandronate and teriparatide on bone mineral density and bone histology in HD patients.
时间窗: one year
次要结局
- Effects of ibandronate and teriparatide on other bone disease markers(one year)
研究者
Efstathios Mitsopoulos
Nephrologist
Papageorgiou General Hospital
研究点 (1)
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