Double Blind Placebo Controlled Trial to Evaluate Preservation of Bone Mineral Density of the Hip and Distal Femur by Biphosphate Therapy (Fosamax) Following Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Bone Mineral Density
研究概览
简要总结
Study is designed to evaluate the efficacy of oral fosamax in prevention on osteoporosis in acute spinal cord injury. Efficacy will be measured by a duel energy X-Ray absorptiometry (DEXA) scan every 6 months. Patients will complete 3 visits, screening, 6 months, 12 months and be required to take oral fosamax versus placebo weekly.
详细描述
The project was funded on August 13, 2009 and was awarded to one of our trainees, Dr. Matthew Abraham, a PGY3 in our program and our IRB approval was obtained with much time and effort on February 24, 2010. We followed the protocol and so far we recruited just one patient on September 19, 2011 who completed the study but we encountered with many unexpected obstacles to recruit any more patients to the study. The main obstacle was that the spine surgeons' refusal to start the study drug for months after surgery for fear of complications with wound healing. Secondly, the few appropriate and eligible patients we tried to recruit declined to participate.
We were unable to recruit any more patients to this study and hence the study was closed.
The one patient that was recruited completed the study. Since it is only one subject in the study, no conclusions can be drawn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Spinal Cord Injury Association (ASIA) A or American Spinal Cord Injury Association (ASIA) B Spinal Cord Injury
排除标准
- •History of hypersensitivity to alendronate or other bisphosphonates
- •esophageal abnormality
- •inability to sit/stand upright for 30 minutes
- •creatinine clearance less than 35 milliliters/minute
- •hypothyroidism
- •malignancy
- •pregnancy
- •prolonged steroid use
研究组 & 干预措施
Fosamax
Fosamax at 70 mgs q weekly by mouth for the duration of the study.
干预措施: Fosamax (Drug)
Placebo Sugar Pill
Double blind study using Fosamax versus placebo. Placebo is an inactive drug.
干预措施: Placebo (Drug)
结局指标
主要结局
Bone Mineral Density
时间窗: 1 year after enrollment
Whether or not Fosamax increases bone mineral density at the hip and distal femur in spinal cord injury induced osteoporosis
次要结局
未报告次要终点
研究者
K. R Poduri
Chair of Department of PM&R
University of Rochester