NCT00738257已完成4 期
A 2 Year Prospective, Multicentre, Open-label, Randomised, Controlled Study to Investigate the Effectiveness of Pamidronate in the Prevention of Bone Loss in de Novo Renal Transplant Patients (With a PTH > 150pg/ml) on a Ciclosporin A and Glucocorticoid Based Immunosuppressive Regimen.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
研究概览
简要总结
The purpose of the study was to evaluate the effect of Pamidronate on bone mineral density loss and fracture rates up to 2 years, in post renal-transplant subjects on a Ciclosporin A and glucocorticoid based immunosuppressive regimen.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First or second kidney transplant recipients, aged 18-75 years, PTH > 150 pg/ml
- •De novo patients scheduled to receive ciclosporin A and prednisolone based immunosuppression.
排除标准
- •Previous or current bone disease unrelated to end stage renal failure.
- •Patients with PTH < 150pg/ml who may be at risk of adynamic bone disease.
- •Treatment at any time with a bisphosphonate.
- •d. Calcitonin treatment during the previous month.
- •Malignancy (current or history within last 5 years)
- •Pregnancy or lactation, or women of childbearing potential unwilling to use an effective form of contraception for the 12 month duration of the study.
- •Protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Parmidronate
Experimental
干预措施: Pamidronate (Drug)
研究者
研究点 (1)
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