UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001474 |
|---|---|
| Receipt number | R000001773 |
| Scientific Title | The factual survey of osteoporosis in inflammatory bowel disease. |
| Date of disclosure of the study information | 2008/11/04 |
| Last modified on | 2008/11/03 15:19:51 |
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Basic information
Public title
The factual survey of osteoporosis in inflammatory bowel disease.
Acronym
The factual survey of osteoporosis in inflammatory bowel disease.
Scientific Title
The factual survey of osteoporosis in inflammatory bowel disease.
Scientific Title:Acronym
The factual survey of osteoporosis in inflammatory bowel disease.
Region
| Japan |
Condition
Condition
inflammatory bowel disease; IBD (Crohn's disease; CD and ulcerative colitis; UC)
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the factual aspects of osteoporosis of IBD patients and their nutrition state, understand the therapeutic aspects of IBD medication, and analyze the risks of osteoporosis in IBD patients.
Basic objectives2
Others
Basic objectives -Others
The evaluation of osteoporosis
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
bone mineral density
Key secondary outcomes
bone metabolic marker determination
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients fulfilling all of the following criteria were subjected to the survey.
1. UC and CD patients who matched the diagnosis of specific disease investigation committee of Japanese ministry of health, labor and welfare and are patients in internal digestive department of Keio Hospital.
2. Patients of age range 20 years old to 50 years old
3. Patients of either gender
4. Patients who understood the purpose of experiment and signed a consent form.
Key exclusion criteria
1. When the patient does not agree to the experiment.
2. When the doctor determines that the survey is not medically or ethically adequate to the patient.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshifumi Hibi |
Organization
School of Medicine, Keio University
Division name
Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuyo Wada |
Organization
School of Medicine, Keio University
Division name
Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
Homepage URL
yasuyowada@a7.keio.jp
Sponsor or person
Institute
Department of Internal Medicine, School of Medicine, Keio University
Institute
Department
Personal name
Funding Source
Organization
Kyorin Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
ASAHI KASEI MEDICAL Co., Ltd
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
| 2008 | Year | 11 | Month | 04 | 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
Date of protocol fixation
| 2008 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 12 | Month | 01 | Day |
Other
Other related information
Cross-sectional analysis using type and severity of IBD, drugs, past history, nutrition state,inflammation evaluation, and laboratory data as the parameters
Management information
Registered date
| 2008 | Year | 11 | Month | 03 | Day |
Last modified on
| 2008 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001773
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
