Unique ID issued by UMIN | UMIN000023992 |
---|---|
Receipt number | R000027605 |
Scientific Title | BONVIVA 100mg tablets drug use results surveillance |
Date of disclosure of the study information | 2016/09/12 |
Last modified on | 2022/01/07 12:42:44 |
BONVIVA 100mg tablets drug use results surveillance
BONVIVA 100mg tablets drug use results surveillance
BONVIVA 100mg tablets drug use results surveillance
BONVIVA 100mg tablets drug use results surveillance
Japan |
Osteoporosis
Medicine in general | Orthopedics |
Others
NO
The primary objective is to determine the following items under the conditions of actual clinical use of BONVIVA 100mg tablets.
1.Adverse drug reaction,APR etc., status/incidence
2.Identification and confirmation of factors which affect safety and efficacy, bone mass density,bone metabolism marker and fracture, profiles
Safety,Efficacy
Safety
1.Adverse drug reaction status/incidence
2.Identification and confirmation of factors which affect safetyprofiles
Efficacy
1.Percent change from baseline in bone mineral density (BMD)
2.Percent change from baseline in bone turnover markers
3.Incidence of new fracture (including exacerbation of fracture)
Observational
Not applicable |
Not applicable |
Male and Female
Patients who have no previous treatment with BONVIVA 100mg tablets for osteoporosis
No criteria
1500
1st name | Nomura |
Middle name | |
Last name | Nomura |
Chugai Pharmaceutical Co. Ltd.
Real World Data Science Dept.
103-8324
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
03-3273-0769
nomuramkt@chugai-pharm.co.jp
1st name | Ayaka |
Middle name | |
Last name | Shimizu |
Chugai Pharmaceutical Co. Ltd.
Real World Data Science Dept.
103-8324
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
03-3273-0905
shimizuayk@chugai-pharm.co.jp
Chugai Pharmaceutical Co. Ltd.
Pharmacovigilance Dept.
Chugai Pharmaceutical Co. Ltd.
Pharmacovigilance Dept.
Profit organization
None
None
None
None
NO
2016 | Year | 09 | Month | 12 | Day |
Unpublished
Completed
2016 | Year | 07 | Month | 19 | Day |
2016 | Year | 07 | Month | 19 | Day |
2016 | Year | 09 | Month | 12 | Day |
2021 | Year | 04 | Month | 30 | Day |
Adverse events
Bone mass density,bone metabolism marker and fracture
2016 | Year | 09 | Month | 09 | Day |
2022 | Year | 01 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027605
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