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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002322
Receipt No. R000002836
Scientific Title Administration time-dependent effects of raloxifen in postmenopausal women with osteoporosis
Date of disclosure of the study information 2009/08/11
Last modified on 2012/07/30

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Basic information
Public title Administration time-dependent effects of raloxifen in postmenopausal women with osteoporosis
Acronym Chronotherapy of raloxifen
Scientific Title Administration time-dependent effects of raloxifen in postmenopausal women with osteoporosis
Scientific Title:Acronym Chronotherapy of raloxifen
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 administraion time-dependent effects of raloxifene 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
Key secondary outcomes Bone metabolism markers
Adverse reactions
Bone density

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Morning-administration of raloxifene
Interventions/Control_2 Evening-administration of raloxifene
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
Need for treatment of osteoporosis
Written informed consent
Key exclusion criteria Treatment with raloxifene or bisphosphonate in the preceding 12 months
Anticoagulant therapy
Inpatients
Current or previous venous thromboembolism
Bedridden subjects
Antiphospholipid antibody syndrome
Possibility of pregnancy
Hypersensitivity to raloxifene
Severe hepatic impairment
Severe renal dysfunction
Other unsuitableness
Target sample size 64

Research contact person
Name of lead principal investigator
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
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Jichi Medical University
Division name Clinical Pharmacology
Zip code
Address
TEL
Homepage URL
Email

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

Funding Source
Organization Japan Research Foundation For Clinical Pharmacology
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Hokuriku Clinical Research Supporting Center
Moka Hospital
Kahoku Central Hospital
Nagai Internal Medicine Clinic
Kanazawa Red Cross Hospital
Shin-Kaminokawa Hospital
Name of secondary funder(s) Japan Osteoporosis Fundation

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

Other administrative information
Date of disclosure of the study information
2009 Year 08 Month 11 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2009 Year 08 Month 07 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2012 Year 04 Month 01 Day
Date of closure to data entry
2012 Year 05 Month 01 Day
Date trial data considered complete
2012 Year 07 Month 30 Day
Date analysis concluded
2012 Year 07 Month 30 Day

Other
Other related information

Management information
Registered date
2009 Year 08 Month 11 Day
Last modified on
2012 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002836

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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