UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of a human anti-RANKL antibody (Denosumab) on prevention of steroid-induced osteoporosis in patients with autoimmune hepatitis (AIH)
Title of the study (Brief title)	Efficacy of Denosumab for steroid-induced osteoporosis in patients with AIH
Region	Japan

Condition
Condition	Biopsy-proven AIH patients who are planned or undergoing oral steroid therapy for more than 3 months
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of denosumab on prevention for steroid-induced osteoporosis with AIH.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Percent changes of bone mineral density (BMD) in 6 months and 12months
Key secondary outcomes	1)Percent changes of bone metabolism markers in 6 months and 12 months 2)Correlation between serum activated vitamin D levels and BMD in 6 months and 12 months

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
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	<Test A; Randomization test: 1)2)> In patients pretreated with bisphosphonates; 1) Discontinue the administration of aredoron acid, risedronic acid, or minodronic acid. Then, 60mg of denosumab will be subcutaneously injected every 6 months for 12 months. All patients will take activated vitamin D. In the case of hypocalcemia, calcium will be administrated appropriately.
Interventions/Control_2	<Test A; Randomization test: 1)2)> 2) Continue the administration of bisphosphonate as heretofore. All patients will take activated vitamin D.
Interventions/Control_3	<Test B; newly intervention> In patients who were not pretreated with bisphosphonates; 60mg of denosumab will be subcutaneously injected every 6 months for 12 months. All patients will take activated vitamin D. In the case of hypocalcemia, calcium will be administrated appropriately.
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Biopsy-proven AIH patients who are planned or undergoing oral steroid therapy for more than 3 months 2)Patients given written consent after being provided with sufficient explanation about participation in this clinical trial
Key exclusion criteria	1)Cancer patients with bone metastasis or expected bone metastasis 2) Hypocalcemia 3) Women who wish to be pregnant or are pregnant, or in lactation 4)Hypersensitivity to the denosumab 5)Cancer patients on cancer treatment or anti-hormonal therapy 6)Dental therapy during this trial 7)Long term use of bisphosphonate and have the possibility of atypical fracture 8)severe skin infection 9)severe impaired renal function (Serum creatinine levels: 2.0mg/dl and higher)
Target sample size	80

Research contact person
Name of lead principal investigator	Kenichi Ikejima
Organization	Juntendo University School of Medicine
Division name	Department of Gastroenterology
Address	2-1-1, Hongo, Bunkyo-ku,Tokyo
TEL	03-3813-3111
Email	ikejima@juntendo.ac.jp

Public contact
Name of contact person	Reiko Yaginuma
Organization	Juntendo University School of Medicine
Division name	Department of Gastroenterology
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Homepage URL
Email	yagirei@juntendo.ac.jp

Sponsor
Institute	Juntendo University School of Medicine
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	none
Organization
Division
Category of Funding Organization	Self funding
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	2014 Year 04 Month 08 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 03 Month 28 Day
Anticipated trial start date	2014 Year 04 Month 08 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	2014 Year 04 Month 07 Day
Last modified on	2016 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015931