UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of glucocorticoid-induced osteoporosis prevention in patients with glomerulonephritis
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Kentaro Nakai
Organization	Kakogawa central city hospital
Division name	department of Nephrology and kidney center
Address	384-1 Hiradu,Yonedacho,Kakogawa city
TEL	0794323531
Email	kentaro-kyu@umin.net

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

Sponsor
Institute	Kakogawa central city hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 06 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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