NCT00460733已完成4 期
Local (Brazil) Study, Multicenter, Opened, Comparative, Randomized, With Parallel Groups, Phase IV, in Post Menopausal Woman With Colles' Fracture of the Risedronate Sodium Usage in the Consolidation and in the Callus of the Colles'Fracture.
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
- Sanofi
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Body mineral density of the 33% radius region and of the UD radius region
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of risedronate sodium (Actonel®) after a wrist fracture in postmenopausal women.
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with description of 2 or more years of Menopause;
- •T-score <= -2.0 sd;
- •Confirmed colles'fracture;
- •Independent for the march (preserved ambulatorial ability);
排除标准
- •Co-morbidities;
- •Regular use of corticosteroids or other anti-resorptive drug in the last year;
- •Use of drugs that can affect the calcium metabolism;
- •Hypersensitivity to risedronate;
- •Previous wrist or forearm fracture;
- •Hypocalcemia;
- •Renal insufficiency;
- •Rheumatic disease;
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
干预措施: Risedronate sodium (Drug)
2
Active Comparator
干预措施: Calcium & Vitamine D3 (Drug)
结局指标
主要结局
Body mineral density of the 33% radius region and of the UD radius region
时间窗: after 90 days of treatment
次要结局
- Size of callus obtained through Rx of the fracture site.(from the beginning up to the end of the study)
- Safety: Adverse events occurrence.(from the inform consent signature up to the end of the study)
- Body mineral density of the 33% radius region and of the UD radius region(after 180 days of treatment)
研究者
研究点 (1)
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