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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011412
Receipt No. 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

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Basic information
Public title Influence of dosing time of bazedoxifene in postmenopausal women with osteoporosis
Acronym Chronotherapy of bazedoxifene
Scientific Title Influence of dosing time of bazedoxifene in postmenopausal women with osteoporosis
Scientific Title:Acronym Chronotherapy of bazedoxifene
Region
Japan

Condition
Condition postmenopausal osteoporosis
Classification by specialty
Medicine in general Endocrinology and Metabolism Geriatrics
Obsterics and gynecology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the dosing time-dependent effects of bazedoxifene on coagulation, fibrinolysis, and osteoprosis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Coagulation and fibrinolysis factors
Bone metabolism markers
Key secondary outcomes Development of thromboembolism and bone fracture
Any other adverse effects
Compliance

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Morning-administration of bazedoxifene
Interventions/Control_2 Evening-administration of bazedoxifene
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Outpatients
Diagnosed postmenopausal osteoporosis
Written informed consent
Key exclusion criteria 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
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akio Fujimura
Organization Jichi Medical University
Division name Clinical Pharmacology
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan
TEL 0285-58-7387
Email akiofuji@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi Ando
Organization Jichi Medical University
Division name Clinical Pharmacology
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan
TEL 0285-58-7388
Homepage URL
Email h-ando@jichi.ac.jp

Sponsor
Institute Division of Clinical Pharmacology,
Department of Pharmacology,
School of Medicine,
Jichi Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 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) 

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 08 Month 06 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 07 Day
Last follow-up date
2016 Year 09 Month 30 Day
Date of closure to data entry
2016 Year 12 Month 31 Day
Date trial data considered complete
2017 Year 02 Month 01 Day
Date analysis concluded
2017 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 08 Month 07 Day
Last modified on
2017 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013359

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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