Autoimmune hepatitis
Conditions
Interventions
Zoledronic acid hydrate group
Other bisphosphonates group
Sponsors
Hyogo college of medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The degree of improvement of bone density after 48 weeks from the start of therapy using dual-energy X-ray absorptiometry. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactYoshiyuki Sakai
Hyogo college of medicine Department of Hepatobiliary and Pancreatic disease, Department of Internal Medicine
Outcome results
None listed