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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004923
Receipt No. R000005859
Scientific Title Fracture risk of diabetic patients
Date of disclosure of the study information 2011/02/01
Last modified on 2013/01/21

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Basic information
Public title Fracture risk of diabetic patients
Acronym Fracture risk of diabetic patients
Scientific Title Fracture risk of diabetic patients
Scientific Title:Acronym Fracture risk of diabetic patients
Region
Japan

Condition
Condition diabetes mellitus
Classification by specialty
Medicine in general Endocrinology and Metabolism Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the proportion of diabetic patients who are at high risk of fracture
Basic objectives2 Others
Basic objectives -Others Prevention of fracture of diabetic patients
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes bone mineral density(lumbar, femoral), TRACP-5b, BAP, osteocalcine, 25(OH)Vit D, intact PTH, pentosidine
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Diabetic patients who showed written informed consent to take part in this study.
Key exclusion criteria Diabetic patients who are in too bad general condition to take part in this study.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tanaka Masami
Organization School of Medicine, Keio University
Division name Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization School of Medicine, Keio University
Division name Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Internal Medicine, School of Medicine, Keio University
Institute
Department

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
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
2011 Year 02 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
2010 Year 11 Month 22 Day
Date of IRB
Anticipated trial start date
2011 Year 02 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 Observation about items below will be investigated .
bone mineral density(lumbar, femoral)
TRACP-5b, BAP
osteocalcine
25(OH)VitD
intact PTH
pentosidine

Management information
Registered date
2011 Year 01 Month 21 Day
Last modified on
2013 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005859

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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