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临床试验/NCT00548288
NCT00548288Unknown1 期

Phase 1 Study of the Effect of Local Pamidronate Application in Preventing Periprosthetic Bone Loss After Total Cemented Hip Arthroplasty

General and Teaching Hospital Celje2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2007年11月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
发起方
入组人数
40
试验地点
2
主要终点
Periprosthetic bone mineral density

研究概览

简要总结

The aims of the study are to determine whether pamidronate applied locally causes diminished periprosthetic bone loss and decreased rate of bone turnover compared to patients receiving placebo after cemented total hip arthroplasty (THA). The study design will be prospective, randomized, and blind. Periprosthetic bone mineral density (BMD) will be measured with dual energy X-ray absorptiometry (DXA) at the total periprosthetic area as well as at seven Gruen zones or regions of interest. DXA scans will be performed at one week (baseline), three months, and six months postoperatively. Mean values of biochemical markers of bone turnover, BMD, and baseline-normalized BMD values will be compared between the bisphosphonate and placebo groups at each time point. For all temporal measurements including bone markers, BMD and normalized BMD, mean values will be compared across each time point within a given group.

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
Single (Participant)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with hip arthritis scheduled for total cemented hip arthroplasty

排除标准

  • pregnancy
  • endoprosthesis on contralateral hip

结局指标

主要结局

Periprosthetic bone mineral density

时间窗: 6 months

次要结局

  • Biochemical markers of bone turnover(6 months)

研究者

发起方
General and Teaching Hospital Celje
申办方类型
Other

研究点 (2)

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