Sodium Risedronate 17.5 mg Tablets Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) - 48-week Surveillance -
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 315
- 主要终点
- Percentage of Participants Who Had One or More Adverse Drug Reactions
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets administered once daily (one tablet per dose) in patients with osseous Paget's disease for 48 weeks from baseline in daily medical practice.
详细描述
This special drug use surveillance was designed to evaluate the safety and efficacy of sodium risedronate tablets 17.5 mg administered once daily (one tablet per dose) in patients with osseous Paget's disease in daily medical practice.
The usual dosage for adults is 17.5 mg of sodium risedronate administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. For at least 30 minutes after administration, participants should avoid lying in a supine position and taking food, drink (except for water) or other oral drugs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osseous Paget's disease patients treated with sodium risedronate tablets 17.5 mg
排除标准
- 未提供
研究组 & 干预措施
17.5 mg of sodium risedronate
17.5 mg of sodium risedronate is administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks.
干预措施: Sodium risedronate (Drug)
结局指标
主要结局
Percentage of Participants Who Had One or More Adverse Drug Reactions
时间窗: Up to 48 weeks
Adverse drug reaction refers to adverse events related to administered drug.
次要结局
- Percentage of Changes From Baseline in Excess Serum Alkaline Phosphatase (ALP) Level at Final Assessment Point(Baseline and final assessment point (Up to 48 weeks))
- Percentage of Changes From Baseline in Serum ALP Level at Final Assessment Point(Baseline and final assessment point (Up to 48 weeks))
- Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point(Baseline and final assessment point (Up to 48 weeks))
- Number of Participants Stratified by Assessment of Image Findings of Bone Morphogenic Abnormalities at Final Assessment Point Compared With Baseline(Baseline and final assessment point (Up to 48 weeks))
- Number of Participants Stratified by Assessment of Image Findings of Trabecular Bone Structural Abnormalities at Final Assessment Point Compared With Baseline(Baseline and final assessment point (Up to 48 weeks))
- Number of Participants Stratified by Assessment of Image Findings of Other Abnormalities at Final Assessment Point Compared With Baseline(Baseline and final assessment point (Up to 48 weeks))
- Percentage of Changes From Baseline in Urinary Type 1 Collagen Cross-Linked N-telopeptide (Urinary NTX) Level at Final Assessment Point(Baseline and final assessment point (Up to 48 weeks))
- Percentage of Changes From Baseline in Urinary Deoxypyridinoline (Urinary DPD) Level at Final Assessment Point(Baseline and final assessment point (Up to 48 weeks))
- Percentage of Changes From Baseline in Serum Bone Alkaline Phosphatase (Serum BAP) Level at Final Assessment Point(Baseline and final assessment point (Up to 48 weeks))
- Percentage of Participants Stratified by Treatment Compliance (Medicine Adherence) During Treatment Period(Up to 48 weeks)