Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Bone Mineral Density of Spine at 12 Months
研究概览
简要总结
Patients with kidney failure have underlying bone disease at the time of transplant. Fractures of various bones can be as high as 22%. Medication required for the transplant plays a role in bone loss.
Bisphosphonates are used in the general population to treat bone loss of osteoporosis and steroid-induced bone loss. While previous studies, using various bisphosphonates, have shown preservation of bone mineral density in renal transplant recipients, we have demonstrated that pamidronate, a second generation bisphosphonate, is associated with low bone turnover while still preserving bone mineral density. Improved bone mineral density is associated with decreased fracture risk in the general population, while low bone turnover may be associated with increased fracture in dialysis patients.
The purpose of this study is to determine whether risedronate, a third generation bisphosphonate, is effective in preserving bone density when given prophylactically following renal transplantation and whether it is associated with low bone turnover at one year following renal transplantation.
详细描述
Participants who receive a living donor kidney transplant undergo a bone biopsy at the time of kidney transplant and after one year of protocol. Once adequate kidney function is established, both groups take by mouth a weekly capsule (the control group has a placebo; the treatment group has risedronate 35 mg). Both groups undergo baseline, 6 month and 12 month dual energy x-ray absorptiometry (DEXA) bone mineral density scans. Both groups undergo bone hormonal studies at regular intervals.
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, Care Provider, Investigator)
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
- •Adults with end stage renal disease who are undergoing living donor kidney transplantation
排除标准
- 未提供
研究组 & 干预措施
Risedronate
subjects received Risedronate for one year
干预措施: Risedronate (Drug)
subjects received placebo
subjects received placebo for 1 year
干预措施: Placebo (Drug)
结局指标
主要结局
Bone Mineral Density of Spine at 12 Months
时间窗: month 12 of treatment
Bone Mineral Density (BMD) measurements were of the vertebral spine (L1-L4) measured using same Hologic 4500 QDC scanner.
Bone Mineral Density of Forearm at 12 Months
时间窗: month 12 of the treatment
Bone mineral density (BMD) of the distal third of the nondialysis access forearm were measured using the Hologic 4500 QDC scanner.
Bone Mineral Density of the Hip at 12 Months
时间窗: month 12 of the treatment
Bone mineral density (BMD) of the total hip were measured using the Hologic 4500 QDC scanner.
Bone Mineral Density of Spine at 6 Months
时间窗: month 6 of the treatment
Bone Mineral Density (BMD) measurements were of the vertebral spine (L1-L4) measured using the Hologic 4500 QDC scanner.
Bone Mineral Density of the Hip at 6 Months
时间窗: month 6 of the treatment
Bone mineral density (BMD) of the total hip were measured using the Hologic 4500 QDC scanner.
Bone Mineral Density of Forearm at 6 Months
时间窗: month 6 of the treatment
Bone mineral density (BMD) of the distal third of the nondialysis access forearm were measured using the Hologic 4500 QDC scanner.
次要结局
- Bone Histomorphometry - Mineralized Bone Volume (MdV)(Baseline and month 12 of the treatment)
- Bone Histomorphometry - Percent Osteoid Volume Relative to Tissue Volume (OV/TV)(Baseline and month 12 of the treatment)
- Bone Histomorphometry - Osteoid Volume (OV)(Baseline and month 12 of the treatment)
- Bone Histomorphometry - Percent Bone Volume (BV/TV)(Baseline and month 12 of the treatment)
- Bone Histomorphometry - Trabecular Thickness (TbTh)(Baseline and month 12 of the treatment)
- Bone Histomorphometry - Percent Mineralized Bone Volume (MdV/BV)(Baseline and month 12 of the treatment)
- Bone Histomorphometry - Percent Osteoid Surface Relative to Bone Surface (OS/BS)(Baseline and month 12 of the treatment)
- Bone Histomorphometry - Bone Formation Rate(Baseline and month 12 of the treatment)
- Bone Histomorphometry - Percent Osteoid Volume Relative to Bone Volume(OV/BV)(Baseline and month 12 of the treatment)
- Bone Histomorphometry - Percent Osteoblasts Relative to Bone Surface (OB/BS)(Baseline and month 12 of the treatment)
- Bone Histomorphometry - Percent Eroded Surface Relative to Bone Surface (ES/BS)(Baseline and month 12 of the treatment)
- Bone Histomorphometry - Percent Osteoclasts Relative to Bone Surface (OC/BS)(Baseline and month 12 of the treatment)