Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy of Disodium Pamidronate in the Treatment of Bone Loss Associated With Liver Transplant
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- bone mineral density (BMD), quantified by dual energy X-ray absorptiometry (DXA)
研究概览
简要总结
The aims of this study are to prospectively evaluate the efficacy of two intravenous infusions of pamidronate 90 mg, associated with calcium and calcidiol, in the early post-transplant period, on bone loss in liver transplant recipients, and to asses the safety of this treatment.
详细描述
Patients diagnosed with chronic advanced liver disease awaiting orthotopic liver transplantation will be eligible to take part in this study.
Patients excluded from the study will be those younger than 18 years, those receiving a multiorgan transplant or retransplant, or patients with a previous allergy to bisphosphonates. Previous treatment with fluoride, estrogens, selective estrogen receptor modulators or bisphosphonates will be another reason for exclusion, as well as therapy with glucocorticoids during the last 6 months before transplantation. None of the patients will have a previous history of disorders, other than liver disease, known to affect bone metabolism.
Study Design and Conduct
The study will be a 1-year prospective, randomized, double-blind, placebo-controlled trial conducted at 10 centers in Spain.
Immunosuppression
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •diagnosed with chronic advanced liver disease awaiting orthotopic liver transplantation
排除标准
- •younger than 18 years
- •receiving a multiorgan transplant or retransplant
- •previous allergy to bisphosphonates
- •Previous treatment with fluoride, estrogens, selective estrogen receptor modulators or bisphosphonates
- •therapy with glucocorticoids during the last 6 months before transplantation
- •previous history of disorders, other than liver disease, known to affect bone metabolism.
研究组 & 干预措施
Pamidronate
Single dose of 90 mg disodium pamidronate within days 7-12 and at 3 months after liver transplantation, diluted in 500 ml of 5% glucose serum and administered as a 4-hour continuous intravenous infusion
干预措施: Disodium pamidronate (Drug)
Placebo
500 ml of 5% glucoside serum infusions within days 7-12 and at 3 months after liver transplantation and administered as a 4-hour continuous intravenous infusion
干预措施: Placebo (Drug)
结局指标
主要结局
bone mineral density (BMD), quantified by dual energy X-ray absorptiometry (DXA)
时间窗: Change during the 1-year of follow up
次要结局
- adverse events(incidence during 1-year of follow-up)
- incidence of skeletal fractures, by assessment of radiological vertebral fractures (symptomatic and asymptomatic),(1-year of follow-up)
- incidence of nonvertebral fractures(1-year follow-up)