Efficacy of Risedronate in Patients With Painful Periprosthetic Resorption of the Hip Prothesis (PTH)
Efficacy of Risedronate in Patients With Painful Periprosthetic Resorption of the Hip Prothesis Double-blind Randomized Study Versus Placebo
This is an experimental study, prospective, comparative. This clinical trial is randomized and double-blind, Residronate versus placebo.
The study aims to demonstrate the effectiveness of risedronate in pain management, after 18 month of traitment, in patients undergoing aseptic joint prosthesis loosening. 2 groups were compared with a 1: 1 ratio. The first group receives active drug (risedronate 75mg) and the second a placebo.
Patients are treated during 18 months: 1 tablet residronate/placebo per os two consecutive days each month.
Evaluations are planned evry 6 months.
研究概览
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Limoges、法国、87100
- Chu Limoges
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Male or female subjects, 18 years of age or older.
- Written informed consent
- Subjects with cemented or not cemented total hip prothesis (for primitive or secondary coxarthrosis)
- Painful aseptic loosening
- Subject has pain 4 or greater on a 10 point Visual Pain Rating scale
- For subject woman of reproductive age, they must use reliable method(s) of contraception and/or abstinence, for the duration of therapeutic product exposure.
Exclusion Criteria:
Subjects with septic loosening of hip prosthesis
. Subjects with bilateral disease
- Subjects with implant mobility associated with pre-operative and intraoperative loosening
- Subjects under anti-osteoporotic treatment
- Subjects having stopped a biphosphonate traetment for less than one year
Subjects with known allergy or sensitivity to any of the components in the study medication.
- Subjects with Hypocalcemia
- Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
- Subjects with severe kidney failure ( creatinine < 30 ml/min)).
- Subjects participation in another research study
- Subjects with previous osteonecrosis of the jaw
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Risedronate
Patients take an oral tablet of Risedronate 75 mg, 2 consecutive days per month during 18 months.
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risedrante tablet (75 mg)
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安慰剂比较:Placebo
Patients take an oral tablet of Placebo, 2 consecutive days per month during 18 months.
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risedrante placebo tablet (75 mg)
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain measurement
大体时间:18, months
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Measurement of pain by means of numerical rating scale.
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18, months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain measurement at walk
大体时间:6 months, 12 months, 18, months, 24 moths
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Measurement of pain by means of numerical rating scale
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6 months, 12 months, 18, months, 24 moths
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Pain measurement at rest
大体时间:6 months, 12 months, 18, months, 24 moths
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Measurement of pain by means of numerical rating scale
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6 months, 12 months, 18, months, 24 moths
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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