Comparison of the Effects of the Direct Thrombin Inhibitor, Pradaxa, to That of Warfarin on Bone Mass and Bone Turnover Markers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in bone mineral density in patients
研究概览
简要总结
The investigators are evaluating the effect of Pradaxa in comparison to warfarin on bone turnover and bone density in men and women with atrial fibrillation.
详细描述
1.0 Hypothesis: The direct thrombin inhibitor Pradaxa positively affects bone turnover markers and increases bone mineral density in women and men at risk for osteoporosis.
2.0 Goal: The goal of this study is to establish if the direct thrombin inhibitor Pradaxa positively affects bone turnover markers and increases bone mineral density in women and men at risk for osteoporosis.
3.0 Specific Aims.
3.1 To determine the effect of Pradaxa on bone mineral density in patients after 6 and 12 months of daily use.
3.2 To determine the effect of the direct thrombin inhibitor Pradaxa on bone turnover markers for osteoclastic resorption (measured as serum levels of C-terminal peptide, and N-telopeptide) and osteoblastic formation (measured as serum levels of bone-specific alkaline phosphatase, osteocalcin and P1NP) in subjects after 6 and 12 months of daily use.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 and above, male and female starting on Pradaxa or Warfarin for nonvalvular atrial fibrillation
- •Able to ambulate independently and travel to UConn Health in Farmington CT-
排除标准
- •Prior known history of osteoporosis
- •Chronic kidney disease with creatinine clearance less than 30
- •Serum 25 hydroxyvitamin D level less than 10
- •Ongoing treatment with medications that interfere with bone metabolism such as steroids, bisphosonates, denosumab, estrogen, SERMS
- •Hypercalcemia, a history of Paget's disease, a history of multiple myeloma, or a history of monoclonal gammopathy of uncertain significance -
结局指标
主要结局
Change in bone mineral density in patients
时间窗: 6 and 12 months
Measurement of bone density using DXA
次要结局
- Change in bone turnover markers(6 and 12 months)