UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004399 |
|---|---|
| Receipt number | R000003605 |
| Scientific Title | Effect of raloxifene on bone metabolism, lipid profile and glucose metabolism in postmenopausal women with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2010/12/01 |
| Last modified on | 2012/02/10 20:20:45 |
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Basic information
Public title
Effect of raloxifene on bone metabolism, lipid profile and glucose metabolism in postmenopausal women with type 2 diabetes mellitus
Acronym
Effect of raloxifene on bone metabolism, lipid profile, and glucose metabolism in postmenopausal women with type 2 diabetes mellitus
Scientific Title
Effect of raloxifene on bone metabolism, lipid profile and glucose metabolism in postmenopausal women with type 2 diabetes mellitus
Scientific Title:Acronym
Effect of raloxifene on bone metabolism, lipid profile, and glucose metabolism in postmenopausal women with type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of raloxifene on lipid profile
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of LDL-C before and after 6 months treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
No therapy
Interventions/Control_2
Alfacalcidol
Interventions/Control_3
Raloxifene 60 mg/day
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
| Not applicable |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
postmenopausal (more than 2 years) women with type 2 diabetes mellitus
Key exclusion criteria
(1)history of phlebothrombosis
(2) bed-ridden people
(3)Anti-phospholipid antibody syndrome;
(4)history of hypersensitivity to raloxifene or alfacalcidol
(5)With effective drug of bone metabolism(bisphosphonates, vitaminK, estrogen, calcium, anabolic steroid, sex hormones)
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiya Tanaka |
Organization
University of Occupational and Environmental Health, School of Medicine, Japan
Division name
The First Department of Internal Medicine
Zip code
Address
1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Okada |
Organization
University of Occupational and Environmental Health, School of Medicine, Japan
Division name
The First Department of Internal Medicine
Zip code
Address
1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555 Japan
TEL
Homepage URL
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
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
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
| 2010 | Year | 12 | Month | 01 | 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
| 2005 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 18 | Day |
Last modified on
| 2012 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003605
