UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006915 |
|---|---|
| Receipt number | R000008170 |
| Scientific Title | Randomized controlled trial for the management of osteoporosis in inflammatory bowel disease |
| Date of disclosure of the study information | 2011/12/20 |
| Last modified on | 2015/06/21 22:09:14 |
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Basic information
Public title
Randomized controlled trial for the management of osteoporosis in inflammatory bowel disease
Acronym
The management of osteoporosis in inflammatory bowel disease
Scientific Title
Randomized controlled trial for the management of osteoporosis in inflammatory bowel disease
Scientific Title:Acronym
The management of osteoporosis in inflammatory bowel disease
Region
| Japan |
Condition
Condition
Inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the treatment strategy of osteoporosis in inflammatory bowel disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone mineral density 12 months after the treatment
Key secondary outcomes
Bone mineral density 12 months after the treatment. Bone markers, disease activity, side effects.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Bisphosphonate (risedoronate)
Interventions/Control_2
Vitamin K (menatetrenone)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Inflammatory bowel disease patients with osteopenia
2)Inflammatory bowel disease patients who were or are going to be treated with corticosteroids (> 5mg/day) for more than 3 months.
Key exclusion criteria
1) Patients already treated for osteoporosis
2) Patients taking warfarin.
3) Patients with stenosis in the esophagus or gut.
4) Patients allergic to medicine.
5) Patients who cannot stand or sit down for more than 30 min.
6) Pregnancy.
7) Patients with severe nephropathy.
8) Patients who are attending other clinical trials.
9) Patients who are not supposed to be suitable for this study by doctors.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuo Takehara |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871
TEL
0668793621
hiijima@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Iijima |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871
TEL
06-6879-3621
Homepage URL
hiijima@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, Osaka University Graduate School of Medicine
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 | 12 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | 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
Management information
Registered date
| 2011 | Year | 12 | Month | 20 | Day |
Last modified on
| 2015 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008170
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
