UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002979 |
|---|---|
| Receipt number | R000003617 |
| Scientific Title | The preventive effect of bisphosphonate to urolithiasis |
| Date of disclosure of the study information | 2010/01/05 |
| Last modified on | 2010/01/05 20:48:01 |
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Basic information
Public title
The preventive effect of bisphosphonate to urolithiasis
Acronym
The preventive effect of bisphosphonate to urolithiasis
Scientific Title
The preventive effect of bisphosphonate to urolithiasis
Scientific Title:Acronym
The preventive effect of bisphosphonate to urolithiasis
Region
| Japan |
Condition
Condition
urolithiasis
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The preventive effect of bisphosphonate to urolithiasis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence of urolithiasis
Key secondary outcomes
Risk-parameter of urolithiasis
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Bisphosphonate
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Pateients with the past of the urolithiasis.
Patients age >= 40 years old, <= 80 years old.
Patients with Inforrmed Concent.
Patients with osteoporosis, but without non-treatment for osteoporosis.
Key exclusion criteria
Patients' stone include no calcium.
Patients with treatment for osteoporosis (vitamine D or elcitonin).
Patiens who were administrated bisphosphonate between the past three years.
Patients with stricture of the esophagus or gullet achalasia.
Patients cannot keep a standing position or seat digit at the time of taking more than 30 minutes.
A pregnant woman or the case of the woman with possibility becoming pregnant.
Patients that takes hormone replacement therapy.
Patients that takes an adrenocorticosteroid drug.
Patients that takes a citric acid drug.
Patients that takes the anti-malignant tumor agent.
Patients that it is judged that medication is not appropriate.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Yasui |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Nephro-urology
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nagoya City University
Division name
Urology
Zip code
Address
TEL
Homepage URL
yasui@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Department of Nephro-urology, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Nephro-urology, Nagoya City University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization
Other
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
| 2010 | Year | 01 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 05 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 05 | 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
| 2010 | Year | 01 | Month | 05 | Day |
Last modified on
| 2010 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003617
| 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 |
