UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023805 |
|---|---|
| Receipt number | R000027428 |
| Scientific Title | Effects of pioglitazone on bone formation and resorption markers in type 2 diabetes mellitus. |
| Date of disclosure of the study information | 2016/08/29 |
| Last modified on | 2016/08/29 09:13:15 |
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Basic information
Public title
Effects of pioglitazone on bone formation and resorption markers in type 2 diabetes mellitus.
Acronym
Effects of pioglitazone on bone
Scientific Title
Effects of pioglitazone on bone formation and resorption markers in type 2 diabetes mellitus.
Scientific Title:Acronym
Effects of pioglitazone on bone
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus.
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we compared the effects of pioglitazone and metformin on bone metabolism in clinical practice using bone metabolic makers, homocystein and pentosidine in Japanese patients with type 2 diabetes mellitus.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was changes in bone resorption markers after 3 months by pioglitazone.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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 group(males 30 mg/day, females 15 mg/day)
3months
Interventions/Control_2
metformin group(750 mg/day)
3months
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The subjects of this research were male and female type 2 diabetes patients, aged less than 80 years, who attended the First Department of Medicine at the University of Occupational and Environmental Health, Japan, and its associated centers between January 2010 and March 2012.
Key exclusion criteria
Patients treated with pioglitazone, metformin or insulin, with type 1 diabetes, history of secondary osteoporosis, heart failure, renal failure, liver failure, and patients receiving any drugs that affect bone metabolism (bisphosphonates, vitamin K, estrogen, calcium, anabolic steroids, or male and female hormones) were excluded from the research.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yosuke Okada |
Organization
University of Occupational and Environmental Health, Japan
Division name
First Department of Internal Medicine, School of Medicine
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-shi 807-8555, Japan
TEL
093-603-1611
y-okada@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroko Mori |
Organization
University of Occupational and Environmental Health, Japan
Division name
First Department of Internal Medicine, School of Medicine
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-shi 807-8555, Japan
TEL
093-603-1611
Homepage URL
morihiro@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
University of Occupational and Environmental Health, Japan
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
| 2016 | Year | 08 | Month | 29 | 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
| 2010 | Year | 01 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 30 | 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
| 2016 | Year | 08 | Month | 29 | Day |
Last modified on
| 2016 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027428
