UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001997 |
|---|---|
| Receipt number | R000002434 |
| Scientific Title | Effects of pioglitazone or metformin on bone markers and bone mineral density as well as parameters of atherosclerosis in patients with type 2 diabetes |
| Date of disclosure of the study information | 2009/05/22 |
| Last modified on | 2009/05/22 12:55:20 |
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Basic information
Public title
Effects of pioglitazone or metformin on bone markers and bone mineral density as well as parameters of atherosclerosis in patients with type 2 diabetes
Acronym
Effects of pioglitazone or metformin on bone metabolism and atherosclerosis
Scientific Title
Effects of pioglitazone or metformin on bone markers and bone mineral density as well as parameters of atherosclerosis in patients with type 2 diabetes
Scientific Title:Acronym
Effects of pioglitazone or metformin on bone metabolism and atherosclerosis
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of pioglitazone or metformin on bone metabolism and atherosclerosis in patients with type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
bone turnover marker, bone mineral density, intima-media thickness, pulse wave velocity
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
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pioglitazone
Interventions/Control_2
Metformin
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Type 2 diabetes
Key exclusion criteria
Nobody had hepatic or renal dysfunction or nutritional derangements. Patients treated with TZDs and metformin were excluded from this study. 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
60
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
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shimane University School of Medicine
Division name
ternal Medicine 1
Zip code
Address
TEL
Homepage URL
ippei.k@med.shimane-u.ac.jp
Sponsor or person
Institute
Department of Internal Medicine 1, Shimane University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2009 | Year | 05 | Month | 22 | 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
In the pioglitazone group bone mineral density at femoral neck and radius were significantly decreased, whereas the parameters of atherosclerosis were not changed. On the other hand, in the metformin group bone mineral density was not changed, whereas the parameters of atherosclerosis 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
| 2006 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 22 | Day |
Last modified on
| 2009 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002434
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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