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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-UMIN000031384 |
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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 and safety of Denosumab treatment for osteoporosis in patients with primary biliary cholangitis; a randomized controlled trial with zoledronic acid (DELTA Study)
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Scientific title:
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Efficacy and safety of Denosumab treatment for osteoporosis in patients with primary biliary cholangitis; a randomized controlled trial with zoledronic acid (DELTA Study) - Efficacy and safety of Denosumab treatment for osteoporosis in patients with primary biliary cholangitis; a randomized controlled trial with zoledronic acid (DELTA Study) |
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Date of first enrolment:
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2018/03/16 |
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Target sample size:
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80 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035832 |
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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 selected
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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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Yoshitaka Arase |
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Address:
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Gakkyo 21-1, Oisotyo, Nakagun, Kanagawa, Japan
Japan |
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Telephone:
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0463-72-3211 |
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Email:
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arase@tokai-u.jp |
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Affiliation:
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Tokai University Oiso Hospital Department of Gastroenterology and Hepatology |
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Name:
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Yoshitaka Arase |
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Address:
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shimokasuya 143, Isehara, Kanagawa, Japan
Japan |
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Telephone:
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0463-93-1121 |
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Email:
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arase@tokai-u.jp |
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Affiliation:
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Tokai University School of Medicine Department of Gastroenterology and Hepatology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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
Age minimum:
20years-old
Age maximum:
89years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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PBC patients with osteoporosis
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Intervention(s)
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Denosumab group (60 mg Denosumab is administered subcutaneously every 6 month)
Zoledronic acid group (5 mg Zoledronic acid is administered intravenously every 12 month)
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Primary Outcome(s)
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Changes in bone density after 12 months treatment (Lumbar spine and proximal femur)
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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Ministry of Health, Labour and Welfare
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Ethics review
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Status: YES
Approval date: 16/02/2018
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/03/2022 |
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URL:
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