Efficacy of Risedronate in Patients With Painful Periprosthetic Resorption of the Hip Prothesis Double-blind Randomized Study Versus Placebo
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Pain measurement
研究概览
简要总结
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Risedronate
Patients take an oral tablet of Risedronate 75 mg, 2 consecutive days per month during 18 months.
干预措施: risedronate (Drug)
Placebo
Patients take an oral tablet of Placebo, 2 consecutive days per month during 18 months.
干预措施: placebo (Drug)
结局指标
主要结局
Pain measurement
时间窗: 18, months
Measurement of pain by means of numerical rating scale.
次要结局
- Pain measurement at rest(6 months, 12 months, 18, months, 24 moths)
- Pain measurement at walk(6 months, 12 months, 18, months, 24 moths)