Efficacy of zoledronic acid hydrate on glucocorticoids-induced osteoporosis for patients with autoimmune hepatitis

Not Applicable

• Conditions: Autoimmune hepatitis

• Registration Number: JPRN-UMIN000031353
• Lead Sponsor: Hyogo college of medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The degree of improvement of bone density after 48 weeks from the start of therapy using dual-energy X-ray absorptiometry.

Secondary Outcome Measures

Name	Time	Method
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.