UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004923 |
|---|---|
| Receipt number | R000005859 |
| Scientific Title | Fracture risk of diabetic patients |
| Date of disclosure of the study information | 2011/02/01 |
| Last modified on | 2013/01/21 17:29:25 |
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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
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
Sponsor or person
Institute
Department of Internal Medicine, School of Medicine, Keio University
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005859
