Overview
36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Sodium Risedronate 75 mg Tablets
Status:
Completed
Completed
Trial end date:
2018-04-30
2018-04-30
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
TakedaTreatments:
Etidronic Acid
Risedronate Sodium
Risedronic Acid
Criteria
Inclusion Criteria: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
Exclusion Criteria:
-