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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000022873
Receipt No. R000026357
Scientific Title Study of glucocorticoid-induced osteoporosis prevention in patients with glomerulonephritis
Date of disclosure of the study information 2016/07/01
Last modified on 2016/06/24

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Basic information
Public title Study of glucocorticoid-induced osteoporosis prevention in patients with glomerulonephritis
Acronym Study of glucocorticoid-induced osteoporosis prevention in patients with glomerulonephritis
Scientific Title Study of glucocorticoid-induced osteoporosis prevention in patients with glomerulonephritis
Scientific Title:Acronym Study of glucocorticoid-induced osteoporosis prevention in patients with glomerulonephritis
Region
Japan

Condition
Condition glomerulonephritis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of denosumab and alendronate sodium in patients with glomerulonephritis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes change of bone mineral density
Key secondary outcomes change of bone turnover markers, proteinuria, kidney function

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 denosumab 60mg subcutaneously once in 6 months
Interventions/Control_2 alendronate sodium 35mg orally every week
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with glomerulonephritis planned to be treated with steroid for over 6 months in our hospital.
Key exclusion criteria 1.Cases where no consent is obtained.
2.Patients allergic to alendronate sodium or denosumab.
3.Patients pregnant or potential.
4.Other cases where physicians regard as inappropriate.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Nakai
Organization Kakogawa central city hospital
Division name department of Nephrology and kidney center
Zip code
Address 384-1 Hiradu,Yonedacho,Kakogawa city
TEL 0794323531
Email kentaro-kyu@umin.net

Public contact
Name of contact person
1st name
Middle name
Last name Kei saitoh
Organization Kakogawa central city hospital
Division name department of Nephrology and kidney center
Zip code
Address 384-1 Hiradu,Yonedacho,Kakogawa city
TEL 0794323531
Homepage URL
Email kei.saitoh0705@gmail.com

Sponsor
Institute Kakogawa central city hospital
Institute
Department

Funding Source
Organization Kakogawa central city hospital
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
2016 Year 07 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 Preinitiation
Date of protocol fixation
2016 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date
2016 Year 07 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
2016 Year 06 Month 24 Day
Last modified on
2016 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026357

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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