Efficacy of a human anti-RANKL antibody (Denosumab) on prevention of steroid-induced osteoporosis in patients with autoimmune hepatitis (AIH)
Not Applicable
- Conditions
- Biopsy-proven AIH patients who are planned or undergoing oral steroid therapy for more than 3 months
- Registration Number
- JPRN-UMIN000013659
- Lead Sponsor
- Juntendo University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Not provided
Exclusion Criteria
1)Cancer patients with bone metastasis or expected bone metastasis 2) Hypocalcemia 3) Women who wish to be pregnant or are pregnant, or in lactation 4)Hypersensitivity to the denosumab 5)Cancer patients on cancer treatment or anti-hormonal therapy 6)Dental therapy during this trial 7)Long term use of bisphosphonate and have the possibility of atypical fracture 8)severe skin infection 9)severe impaired renal function (Serum creatinine levels: 2.0mg/dl and higher)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent changes of bone mineral density (BMD) in 6 months and 12months
- Secondary Outcome Measures
Name Time Method 1)Percent changes of bone metabolism markers in 6 months and 12 months 2)Correlation between serum activated vitamin D levels and BMD in 6 months and 12 months