NCT01267279已完成4 期
Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty
Spokane Joint Replacement Center0 个研究点目标入组 51 人开始时间: 2005年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 主要终点
- Bone Mineral Density (BMD)
研究概览
简要总结
In a randomized, double-blind trial, BMD of the operated proximal femur after total hip replacement measured by dual-energy x-ray absorptiometry (DXA) were compared for up to two years in patients receiving IV ZOL 5 mg infusion (n = 27) or placebo (IV saline infusion; n = 24) at two weeks and one year after surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing primary elective total hip replacement
排除标准
- •Osteoporosis (BMD ≤-2.5)
- •Trauma to the operated femur, hip revisions, femoral dysplasia, trochanteric osteotomy, inflammatory arthritis
- •Severe renal impairment
- •Use of any medications affecting BMD
- •Known sensitivity to bisphosphonates
- •Severe dental problems, and pregnancy or being able to conceive and not using reliable birth control methods
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Other)
Zoledronic Acid
Experimental
干预措施: Zoledronic acid (Drug)
结局指标
主要结局
Bone Mineral Density (BMD)
时间窗: 2 years post-operative
Change in bone mineral density (BMD) (per dual energy x-ray absorptiometry (DXA) imaging) from 1 week post-operative data in the Standard and Custom Gruen Zones around the femoral stem.
次要结局
未报告次要终点
研究者
David F. Scott, MD
PI
Spokane Joint Replacement Center
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