Benet 75 mg Tablets Special Drug Use Surveillance: Long-term Use (12-month Treatment Survey)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,304
- 主要终点
- Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets (Benet 75 mg Tablets) in osteoporosis patients in daily medical practice, as well as to examine "the status of treatment compliance" - i.e., whether sodium risedronate tablets are taken properly in accordance with the prescribed once-monthly regimen
详细描述
This surveillance was designed to evaluate the safety and efficacy of sodium risedronate tablets (Benet 75 mg Tablets) as well as to evaluate the status of treatment compliance in osteoporosis patients in daily medical practice.
The usual dosage for adult is 75 mg of sodium risedronate administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. For at least 30 minutes after administration, patients should avoid lying in a supine position and should avoid taking food, drink (except for water) or other oral drugs. For more details, see the "Precautions related to dosage and administration" section of the package insert.
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
- •Osteoporosis patients
排除标准
- 未提供
研究组 & 干预措施
75 mg of sodium risedronate
75 mg of sodium risedronate is administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking.
干预措施: Sodium Risedronate (Drug)
结局指标
主要结局
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
时间窗: Up to Month 12
Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of sodium risedronate, whether or not it was considered related to the treatment.
次要结局
- Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment(Baseline and final assessment (up to Month 12))
- Percent Change From Baseline in Femur (Neck Region) BMD at Final Assessment(Baseline and final assessment (up to Month 12))
- Percent Change From Baseline in Radius BMD at Final Assessment(Baseline and final assessment (up to Month 12))
- Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment(Baseline and final assessment (up to Month 12))
- Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment(Baseline and final assessment (up to Month 12))
- Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment(Baseline and final assessment (up to Month 12))
- Change From Baseline in Height(Baseline and final assessment (up to Month 12))
- Number of Participants Who Had Lumbar Backache at Final Assessment(Final assessment (Month 12))
- Percent Change From Baseline in Femur (Total Proximal Femur) BMD at Final Assessment(Baseline and final assessment (up to Month 12))
- Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment(Baseline and final assessment (up to Month 12))
- Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment(Baseline and final assessment (up to Month 12))