UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002561 |
|---|---|
| Receipt number | R000003130 |
| Scientific Title | Prevention of bone fracture by intervening in bone quality in type 2 diabetes |
| Date of disclosure of the study information | 2009/09/30 |
| Last modified on | 2016/07/06 00:59:00 |
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Basic information
Public title
Prevention of bone fracture by intervening in bone quality in type 2 diabetes
Acronym
BBQ-T2DM
Scientific Title
Prevention of bone fracture by intervening in bone quality in type 2 diabetes
Scientific Title:Acronym
BBQ-T2DM
Region
| Japan |
Condition
Condition
bone fracture
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
cohort study concerning whether intervention in bone quality (by administeration of Vit.B12) improves risk against bone fracture in type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
risk reduction in intervention group in 5 years using cox proportional hazard regression model.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Vit.B12 1500ug daily p.o.
Interventions/Control_2
none
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
type 2 diabetes mellitus
agreed to examine bone density, bone X ray, blood and unine analyses every year
agreed to be randamized to administer Vit.B12
not use VitB.12 more than one month
Key exclusion criteria
unable to perform examinations, nor administering vit.B12
unable to wash out Vit.B12
severe, life threatening complications
using medicines prohibited to use in combination
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akifumi Kushiyama |
Organization
The Institute for Adult Disease, Asahi Life Foundation
Division name
div. of mebolic diseases
Zip code
Address
1-6-1, Marunouchi, Chiyoda-ku, Tokyo, Japan
TEL
03-3639-5501
kusiyaa-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kushiyama Akifumi |
Organization
The Institute for Adult Disease, Asahi Life Foundation
Division name
div. of mebolic diseases
Zip code
Address
2-2-6, Nihonbashi Bakurocho, Chuo-ku, Tokyo, Japan
TEL
03-3201-6781
Homepage URL
http://www.asahi-life.or.jp
kusiyaa-tky@umin.ac.jp
Sponsor or person
Institute
The Institute for Adult Disease, Asahi Life Foundation
Institute
Department
Personal name
Funding Source
Organization
The Institute for Adult Disease, Asahi Life Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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 | 09 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 29 | Day |
Last modified on
| 2016 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003130
