36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Benet 75 mg Tablets
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 579
- 主要终点
- Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures
研究概览
简要总结
The purpose of this survey is to evaluate the effectiveness (endpoints: frequency of bone fractures, percent change in bone density, etc.) and safety of administration of sodium risedronate tablets 75 mg for 36 months in osteoporosis patients in daily medical practice.
详细描述
This special drug use surveillance was designed to evaluate the effectiveness (endpoints: frequency of bone fractures, percent change from baseline in bone density, etc.) and safety of sodium risedronate 75 mg tablets 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoporosis patients who meet all the following criteria:
- •Patients with 1 to 4 confirmed vertebral body fractures in the T4-L4 region by thoracic and lumbar spine X-ray examination at screening (within 3 months before the start of administration of sodium risedronate 75 mg tablets)
- •Male and postmenopausal female patients aged 50 years or older
- •Ambulatory outpatients
排除标准
- 未提供
研究组 & 干预措施
Sodium Risedronate 75 mg
75 mg of sodium risedronate is administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants receive sodium risedronate 75 mg as part of routine medical care.
干预措施: Sodium risedronate (Drug)
结局指标
主要结局
Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures
时间窗: From baseline up to Month 36
The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.
次要结局
- Cumulative Percentage of Participants With Non-Vertebral Body Fractures(From baseline up to Month 36)
- Cumulative Percentage of Participants With Femur Fractures(From baseline up to Month 36)
- Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment (up to Month 36)(Baseline and final assessment (up to Month 36))
- Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)(Baseline and final assessment (up to Month 36))
- Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment (up to Month 36)(Baseline and final assessment (up to Month 36))
- Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment (up to Month 36)(Baseline and final assessment (up to Month 36))
- Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment (up to Month 36)(Baseline and final assessment (up to Month 36))
- Percent Change From Baseline in Femur Neck BMD at Final Assessment (up to Month 36)(Baseline and final assessment (up to Month 36))
- Percent Change From Baseline in Total Proximal Femur BMD at Final Assessment (up to Month 36)(Baseline and final assessment (up to Month 36))
- Percent Change From Baseline in Radius BMD at Final Assessment (up to Month 36)(Baseline and final assessment (up to Month 36))
- Change From Baseline in Height at Final Assessment (up to Month 36)(Baseline and final assessment (up to Month 36))
- Number of Participants Who Had Lumbar Backache at Final Assessment (up to Month 36)(Final assessment (up to Month 36))
- Number of Participants Who Had One or More Adverse Drug Reactions(Up to Month 36)
- Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)(Baseline and final assessment (up to Month 36))