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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031353
Receipt No. R000035794
Scientific Title Efficacy of zoledronic acid hydrate on glucocorticoids-induced osteoporosis for patients with autoimmune hepatitis
Date of disclosure of the study information 2018/02/20
Last modified on 2018/02/20

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Basic information
Public title Efficacy of zoledronic acid hydrate on glucocorticoids-induced osteoporosis for patients with autoimmune hepatitis
Acronym Zoledronic acid hydrate and autoimmune hepatitis
Scientific Title Efficacy of zoledronic acid hydrate on glucocorticoids-induced osteoporosis for patients with autoimmune hepatitis
Scientific Title:Acronym 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
1st name
Middle name
Last name Shuhei Nishiguchi
Organization Hyogo college of medicine
Division name Department of Hepatobiliary and Pancreatic disease, Department of Internal Medicine
Zip code
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
1st name
Middle name
Last name Yoshiyuki Sakai
Organization Hyogo college of medicine
Division name Department of Hepatobiliary and Pancreatic disease, Department of Internal Medicine
Zip code
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)

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
2018 Year 02 Month 20 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
2018 Year 01 Month 15 Day
Date of IRB
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

Other
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

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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