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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000031353 |
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Date of registration:
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20/02/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy of zoledronic acid hydrate on glucocorticoids-induced osteoporosis for patients with autoimmune hepatitis
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Scientific title:
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Efficacy of zoledronic acid hydrate on glucocorticoids-induced osteoporosis for patients with autoimmune hepatitis - Zoledronic acid hydrate and autoimmune hepatitis |
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Date of first enrolment:
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2018/03/01 |
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Target sample size:
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40 |
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Recruitment status: |
Pending |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035794 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not applicable
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Countries of recruitment
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Japan
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Contacts
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Name:
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Yoshiyuki Sakai |
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Address:
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1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, Japan
Japan |
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Telephone:
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0798-45-6472 |
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Email:
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kantan@hyo-med.ac.jp |
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Affiliation:
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Hyogo college of medicine Department of Hepatobiliary and Pancreatic disease, Department of Internal Medicine |
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Name:
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Shuhei Nishiguchi |
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Address:
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1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, Japan
Japan |
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Telephone:
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0798-45-6472 |
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Email:
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kantan@hyo-med.ac.jp |
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Affiliation:
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Hyogo college of medicine Department of Hepatobiliary and Pancreatic disease, Department of Internal Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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.
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Autoimmune hepatitis
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Intervention(s)
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Zoledronic acid hydrate group
Other bisphosphonates group
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Primary Outcome(s)
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The degree of improvement of bone density after 48 weeks from the start of therapy using dual-energy X-ray absorptiometry.
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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Hyogo college of medicine
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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