Assessment of Vertebral Fracture Risk Using VFA and Vertebral Strength Assessment With DXA-Finite Element Analysis in Liver Transplant Recipients in Pretransplant Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Incident of clinical fractures validated by spine x-ray or other imaging (vertebral fracture assessment -VFA)
研究概览
简要总结
The researchers are trying to compare the effectiveness of Vertebral Fracture Assessment (VFA) in addition to the current standard of care spine x-ray in evaluation pre-liver transplant patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 是
入选标准
- •First time liver transplant candidates deemed too early for liver transplant
- •24 hour urine Creatinine clearance of > 40 mg/dl. However bone turnover markers (beta CTx and P1NP) will be measured only in those with creatinine clearance >60mg/dl
排除标准
- •Patients with prior solid organ transplantation
- •Liver/kidney combination will be excluded
- •Patients with 24 hr. urine creatinine clearance < 40mL/minute
- •Patients who have been on osteoporosis medications - Bisphosphonates [Fosamax (Alendronate), Actonel (Risedronate), Boniva (Ibandronate), or Reclast (Zoledronic acid)] Teriparatide (Forteo), Abaloparatide (Tymlos), Denosumab (Prolia), within the past 5 years
- •Use of other systemic medications that can effect bone remodeling including sex hormone replacement therapy (estrogen or testosterone), calcitonin, androgen deprivation therapy, aromatase inhibitors, or SERMS in the past 6 months
- •Underlying disease that significantly impacts bone metabolism such as primary hyperparathyroidism, hyperthyroidism, Paget's disease of bone, fibrous dysplasia, or malignancies with skeletal metastases
研究组 & 干预措施
Vertebral fracture assessment
Study participants undergoing evaluation for liver transplant and deemed to early for transplant will receive standard of care bone mineral density and vertebral fracture assessment..
干预措施: Dual x-ray absorptiometry (Diagnostic Test)
Vertebral fracture assessment
Study participants undergoing evaluation for liver transplant and deemed to early for transplant will receive standard of care bone mineral density and vertebral fracture assessment..
干预措施: Vertebral Fracture Assessment (Other)
结局指标
主要结局
Incident of clinical fractures validated by spine x-ray or other imaging (vertebral fracture assessment -VFA)
时间窗: 24 months
Proportion of participants experiencing a clinical fracture validated by x-ray or other imaging (VFA) as compared to standard of care ( Spine X-ray)
次要结局
- Changes in bone mineral density by dual x-ray absorptiometry(24 months)
- Changes in bone turnover markers in end stage liver disease(24 months)
- Percent changes from baseline to 12 months estimation of bone strength derived from finite element analysis(24 months)
研究者
Ejigayehu G. Abate
Assistant Professor of medicine
Mayo Clinic