Unique ID issued by UMIN | UMIN000011412 |
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Receipt number | R000013359 |
Scientific Title | Influence of dosing time of bazedoxifene in postmenopausal women with osteoporosis |
Date of disclosure of the study information | 2013/08/07 |
Last modified on | 2017/02/07 10:06:42 |
Influence of dosing time of bazedoxifene in postmenopausal women with osteoporosis
Chronotherapy of bazedoxifene
Influence of dosing time of bazedoxifene in postmenopausal women with osteoporosis
Chronotherapy of bazedoxifene
Japan |
postmenopausal osteoporosis
Medicine in general | Endocrinology and Metabolism | Geriatrics |
Obstetrics and Gynecology | Orthopedics |
Others
NO
To investigate the dosing time-dependent effects of bazedoxifene on coagulation, fibrinolysis, and osteoprosis.
Safety,Efficacy
Exploratory
Pragmatic
Phase IV
Coagulation and fibrinolysis factors
Bone metabolism markers
Development of thromboembolism and bone fracture
Any other adverse effects
Compliance
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is considered as a block.
NO
Numbered container method
2
Treatment
Medicine |
Morning-administration of bazedoxifene
Evening-administration of bazedoxifene
20 | years-old | <= |
Not applicable |
Female
Outpatients
Diagnosed postmenopausal osteoporosis
Written informed consent
Treatment with bazedoxifene, raloxifene or bisphosphonate in the preceding 12 months
Anticoagulant therapy
Inpatients
Current or previous thromboembolic disease
Bedridden subjects
Antiphospholipid antibody syndrome
Possibility of pregnancy
Pregnant or nursing women
Hypersensitivity to bazedoxifene
Severe hepatic impairment
Severe renal dysfunction
Other unsuitableness
60
1st name | |
Middle name | |
Last name | Akio Fujimura |
Jichi Medical University
Clinical Pharmacology
3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan
0285-58-7387
akiofuji@jichi.ac.jp
1st name | |
Middle name | |
Last name | Hitoshi Ando |
Jichi Medical University
Clinical Pharmacology
3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan
0285-58-7388
h-ando@jichi.ac.jp
Division of Clinical Pharmacology,
Department of Pharmacology,
School of Medicine,
Jichi Medical University
None
Self funding
NO
自治医科大学附属病院(栃木県) Jichi Medical University Hospital (Tochigi)
相模原市立藤野診療所(神奈川県) Fujino Clinic (Kanagawa)
相模原市立千木良診療所(神奈川県) Chigira Clinic (Kanagawa)
相模原市立青野原診療所(神奈川県) Aonohara Clinic (Kanagawa)
2013 | Year | 08 | Month | 07 | Day |
Unpublished
Completed
2013 | Year | 08 | Month | 06 | Day |
2013 | Year | 08 | Month | 07 | Day |
2016 | Year | 09 | Month | 30 | Day |
2016 | Year | 12 | Month | 31 | Day |
2017 | Year | 02 | Month | 01 | Day |
2017 | Year | 05 | Month | 31 | Day |
2013 | Year | 08 | Month | 07 | Day |
2017 | Year | 02 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013359
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