UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of zoledronic acid hydrate on glucocorticoids-induced osteoporosis for patients with autoimmune hepatitis
Title of the study (Brief title)	Zoledronic acid hydrate and autoimmune hepatitis
Region	Japan

Condition
Condition	Autoimmune hepatitis
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aims of this study are to clarify the efficacy of zoledronic acid hydrate on glucocorticoids-induced osteoporosis for patients with autoimmune hepatitis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The degree of improvement of bone density after 48 weeks from the start of therapy using dual-energy X-ray absorptiometry.
Key secondary outcomes	Muscle mass and fat mass as assessed by bioimpedance analysis Evaluation for energy metabolism using indirect calorimetry Evaluation for protein metabolism (serum albumin, prealbumin and retinol binding protein) Laboratory parameters and physical examinations These will be tested at baseline, 12, 24, 36 and 48 weeks.

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Zoledronic acid hydrate group
Interventions/Control_2	Other bisphosphonates group
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	1. AIH patients undergoing corticosteroids therapy 2. Patients who are eligible for corticosteroids-induced osteoporosis 3. Patients aged 20 years or more 4. Patients with Child-Pugh score 10 points or less 5. Patients whose daily life is autonomous for more than one year 6. Patients who are expected to consume adequate dietary intake 7. Previous nutritional therapies such as branched-chain amino acid granules are not limited. 8. Patients who obtained written informed consent by the patients' free will after taking full explanation of this study.
Key exclusion criteria	1. Patients with Child-Pugh score 11 points or more 2. Patients who received bisphosphonates or denosumab within 3 years prior to this study 3. Patients with a history of hypersensitivity to the ingredients of study drugs or other bisphosphonates 4. Patients with severe renal dysfunction (creatinine clearance <35ml/min) 5. Patients with dehydration state caused by high grade fever, severe diarrhea and vomiting. 6. Patients with hypocalcemia. 7. Pregnant patients or patients who are expected to be pregnant 8. Patients with severe comorbid diseases. Severe comorbid diseases indicate advanced malignancies, severe infection and bed rest state which can affect the interpretation for data of bone density. 9. Patients who are judged to be ineligible for the study subjects by investigators.
Target sample size	40

Research contact person
Name of lead principal investigator	Shuhei Nishiguchi
Organization	Hyogo college of medicine
Division name	Department of Hepatobiliary and Pancreatic disease, Department of Internal Medicine
Address	1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, Japan
TEL	0798-45-6472
Email	kantan@hyo-med.ac.jp

Public contact
Name of contact person	Yoshiyuki Sakai
Organization	Hyogo college of medicine
Division name	Department of Hepatobiliary and Pancreatic disease, Department of Internal Medicine
Address	1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, Japan
TEL	0798-45-6472
Homepage URL
Email	kantan@hyo-med.ac.jp

Sponsor
Institute	Hyogo college of medicine
Institute
Department

Funding Source
Organization	Hyogo college of medicine
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	2018 Year 02 Month 20 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 01 Month 15 Day
Anticipated trial start date	2018 Year 03 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	2018 Year 02 Month 18 Day
Last modified on	2018 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035794