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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001992
Receipt No. R000002429
Scientific Title Effects of risedronate and alfacalcidol on parameters of atherosclerosis in type 2 diabetes patients with osteoporosis
Date of disclosure of the study information 2009/05/21
Last modified on 2009/06/21

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Basic information
Public title Effects of risedronate and alfacalcidol on parameters of atherosclerosis in type 2 diabetes patients with osteoporosis
Acronym Effects of risedronate and alfacalcidol on parameters of atherosclerosis
Scientific Title Effects of risedronate and alfacalcidol on parameters of atherosclerosis in type 2 diabetes patients with osteoporosis
Scientific Title:Acronym Effects of risedronate and alfacalcidol on parameters of atherosclerosis
Region
Japan

Condition
Condition Type 2 diabetes with osteoporosis
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of treatment with risedronate and alfacalcidol on parameters of atherosclerosis in Japanese postmenopausal women with type 2 diabetes associated with osteoporosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Plaque score and abdominal aortic calcification score
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treatment with risedronate and alfacalcidol
Interventions/Control_2 No treatment
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
50 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Postmenopausal women with newly diagnosed osteoporosis, who visited our out clinic for education, evaluation, or treatment of type 2 diabetes, were enrolled if informed consent was obtained after a detailed explanation of the study purpose and methods.
Key exclusion criteria Nobody had hepatic or renal dysfunction or nutritional derangements. All patients were free of drugs known to influence bone and calcium metabolism, such as vitamin D, bisphosphonate, or estrogen, up until the time of the study.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ippei Kanazawa
Organization Shimane University School of Medicine
Division name Internal Medicine 1
Zip code
Address 89-1 Enya-cho, Izumo, Shimane
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Shimane University School of Medicine
Division name Internal Medicine 1
Zip code
Address
TEL
Homepage URL
Email ippei.k@med.shimane-u.ac.jp

Sponsor
Institute Department of Internal Medicine 1, Shimane University School of Medicine
Institute
Department

Funding Source
Organization Department of Internal Medicine 1, Shimane University School of Medicine
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

Other administrative information
Date of disclosure of the study information
2009 Year 05 Month 21 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
After 1 year treatment with risedronate and alfacalcidol, plaque score and abdominal aortic calcification score in the osteoporosis group were not statistically changed, while both two parameters in the control group were significantly increased
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
2008 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2009 Year 06 Month 01 Day
Date of closure to data entry
2009 Year 06 Month 01 Day
Date trial data considered complete
2009 Year 06 Month 01 Day
Date analysis concluded
2009 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 05 Month 21 Day
Last modified on
2009 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002429

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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