Efficacy and safety of Denosumab treatment for osteoporosis in patients with primary biliary cholangitis; a randomized controlled trial with zoledronic acid (DELTA Study)
Not Applicable
- Conditions
- PBC patients with osteoporosis
- Registration Number
- JPRN-UMIN000031384
- Lead Sponsor
- Tokai University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients with hypocalcemia (serum calcium level < 8.4 mg / dl) 2) Patients with severe renal dysfunction (eGFR 35 < mL / min / 1.73 m2) 3) Patients with Child-Pugh classification grade B or C 4) Patients with total bilirubin > 5 mg / dl 5) Patients complicated of ascites 6) Patients complicated of poor control of hepatic encephalopathy 7) Patients with uncontrolled malignant tumor 8) Patients needing dental treatment 9) Patients undergoing corticosteroids therapy 10) Patients with a history of hypersensitivity to denosumab, zoledronic acid hydrate or other bisphosphonate 11) Patients who are judged inappropriate by researchers
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in bone density after 12 months treatment (Lumbar spine and proximal femur)
- Secondary Outcome Measures
Name Time Method Changes in bone density after 6 months treatment (Lumbar spine and proximal femur) Changes in bone metabolism marker (serum TRACP-5b, serum CTx, serum BAP, serum P1NP) Changes in bone mineral metabolism (ALP, Ca, P, intact PTH, 25(OH)D) Changes in liver function (PT%, AST, ALT, GGT, Alb, T-Bil, D-Bil) Changes in renal function (Cr, BUN, eGFR) Incidence of new fractures (vertebral fractures, non-vertebral fractures) Adverse events