36-month Special Drug Use Surveillance on Frequency of Bone Fractures with Sodium Risedronate 75 mg Tablets
- Conditions
- Osteoporosis
- Registration Number
- JPRN-jRCT1080222429
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
In conclusion, no new problem of Benet was detected in terms of the safety or efficacy in clinical settings. In addition, as high as 83.24% to 95.38% of patients took the drug as instructed by a physician from the start of Benet treatment to the 36th dose (3 years), and the median dosing interval between two consecutive doses was 30.0 to 31.0 days, showing a good treatment status. Refer to summary of the special drug use surveillance in "Secondary Outcome Measures" section for others.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 579
Osteoporosis patients who meet all the following criteria:
1. 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)
2. Male and postmenopausal female patients aged 50 years or older
3. Ambulatory outpatients
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Cumulative Percentage of Participants with New or Worsening Vertebral Body Fractures<br>Timeframe: From baseline up to Month 36
- Secondary Outcome Measures
Name Time Method