UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002322 |
|---|---|
| Receipt number | 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 14:46:45 |
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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 |
| Obstetrics 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
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
Sponsor or person
Institute
Division of Clinical Pharmacology,
Department of Pharmacology,
School of Medicine,
Jichi Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002836
