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临床试验/NCT00302627
NCT00302627已完成不适用

Pamidronate, Vitamin D, and Calcium for the Bone Disease of Kidney and Heart Transplantation

Providence Health & Services1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 1999年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
1
主要终点
Bone mineral density measured by dual-energy X-ray absorptiometry

研究概览

简要总结

Bone is lost rapidly and fractures occur in 10-20% of patients who receive organ transplants within 2 years. The purpose of this study is to evaluate long-term effects of a pamidronate-vitamin D-calcium regimen on bone loss, fractures, and safety in recipients of kidney and heart transplants.

详细描述

Pamidronate improves bone mass in numerous disorders of bone. Other bisphosphonates, as well as pamidronate, have been proven to be beneficial in steroid-related bone disorders. Steroid treatment is a major cause of bone loss after organ transplantation. Small, short-term studies suggest that pamidronate prevents bone loss in kidney and heart transplant recipients.

Many bisphosphonates cannot be used in patients with decreased kidney function. However, pamidronate can be given to these patients. This is an advantage of pamidronate in kidney and heart transplantation because of the frequent occurrence of decreased kidney function in these groups. Another advantage of pamidronate is that it is administered intravenously. Oral bisphosphonates commonly produce esophagitis, which is a challenging problem in the transplant population. Potential side-effects of pamidronate include transient hypocalcemia, lymphopenia, low-grade fever, myalgias and nausea. Recently, rare cases of proteinuria and kidney failure were reported in cancer patients receiving high-dose pamidronate. Although this side effect has not been reported in other types of patients receiving pamidronate, this is a safety concern that warrants further scrutiny in the transplant population.

In addition to bisphosphonate treatment, supplementation with calcium and vitamin D may preserve bone after organ transplantation. Prior studies have compared bisphosphonates to calcium and vitamin D regimens. However, a combination regimen including each of these treatments may preserve bone mass better than a single treatment. Data regarding treatment with a combination of a bisphosphonate, calcium, and vitamin D are lacking in kidney and heart transplantation.

Comparison(s): In a prospective, open-label, single arm trial, Pamidronate (60-90 mg) is administered within 2 weeks after kidney or heart transplant and every 6 months for 2 years. Participants are prescribed vitamin D 800 units/d or calcitriol 0.25 microgram/d if serum creatinine is greater than 2 mg/dl, and calcium carbonate 1500 mg/d.

The primary outcome is bone mineral density measured by dual-energy X-ray absorptiometry at baseline and after years 1 and 2. Fracture events and serum calcium, parathyroid hormone, creatinine, and dipstick proteinuria are also measured.

研究设计

研究类型
Interventional
分配方式
Na
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

入选标准

  • Kidney or heart transplant recipients

排除标准

  • Hyperparathyroidism

研究组 & 干预措施

Pamidronate, Vitamin D, and Calcium

Experimental

60mg or 90mg given at baseline, 6,12,18, and 24 months

vitamin D 800 units/day

calcium carbonate 1500 milligrams/day

干预措施: Pamidronate (Drug)

Pamidronate, Vitamin D, and Calcium

Experimental

60mg or 90mg given at baseline, 6,12,18, and 24 months

vitamin D 800 units/day

calcium carbonate 1500 milligrams/day

干预措施: vitamin D (Drug)

Pamidronate, Vitamin D, and Calcium

Experimental

60mg or 90mg given at baseline, 6,12,18, and 24 months

vitamin D 800 units/day

calcium carbonate 1500 milligrams/day

干预措施: Calcium Carbonate (Drug)

结局指标

主要结局

Bone mineral density measured by dual-energy X-ray absorptiometry

时间窗: Every 12 months

Performed at 1 year and 2 years.

次要结局

  • proteinuria(Every 6 months)
  • serum calcium(Every 6 months)
  • Fracture events(Every 6 months)
  • serum creatinine and estimated glomerular filtration rate(Every 6 months)
  • parathyroid hormone(Every 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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