UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031353 |
|---|---|
| Receipt number | 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 07:23:52 |
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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
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
kantan@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo college of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035794
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| Registered date | File name |
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| Registered date | File name |
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