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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002979
Receipt No. 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

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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
Email

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
Email yasui@med.nagoya-cu.ac.jp

Sponsor
Institute Department of Nephro-urology, Nagoya City University Graduate School of Medical Sciences
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003617

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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