Unique ID issued by UMIN | UMIN000031384 |
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Receipt number | R000035832 |
Scientific Title | Efficacy and safety of Denosumab treatment for osteoporosis in patients with primary biliary cholangitis; a randomized controlled trial with zoledronic acid (DELTA Study) |
Date of disclosure of the study information | 2018/02/20 |
Last modified on | 2022/08/25 13:46:20 |
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)
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)
Japan |
PBC patients with osteoporosis
Hepato-biliary-pancreatic medicine |
Others
NO
This study aims to compare the efficacy and safety in randomized administration of Denosumab and Zoledronic acid for osteoporosis in patients with primary biliary cholangitis.
Safety,Efficacy
Changes in bone density after 12 months treatment (Lumbar spine and proximal femur)
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Central registration
2
Treatment
Medicine |
Denosumab group
(60 mg Denosumab is administered subcutaneously every 6 month)
Zoledronic acid group
(5 mg Zoledronic acid is administered intravenously every 12 month)
20 | years-old | <= |
89 | years-old | > |
Male and Female
1) Patients diagnosed with PBC based on PBC clinical practice guideline 2017 edited by the Ministry of Health, Labor and Welfare
2) Postmenopausal women or men aged 20 years or older, 89 years or younger
3) Patients with the bone density of the lumbar spine (L1-L4) or the proximal part of the femur using dual-energy X-ray absorptiometry is less than 70% (T score -2.5) of young adult mean (YAM)
4) Patients with not previously treated or treated with bisphosphonate treatment
5) Patients who can walk freely
6) Patients who received explanation sufficiently for participation in this study, and obtained written informed consent by their own intention
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
80
1st name | |
Middle name | |
Last name | Yoshitaka Arase |
Tokai University School of Medicine
Department of Gastroenterology and Hepatology
shimokasuya 143, Isehara, Kanagawa, Japan
0463-93-1121
arase@tokai-u.jp
1st name | |
Middle name | |
Last name | Yoshitaka Arase |
Tokai University Oiso Hospital
Department of Gastroenterology and Hepatology
Gakkyo 21-1, Oisotyo, Nakagun, Kanagawa, Japan
0463-72-3211
arase@tokai-u.jp
Tokai University School of Medicine
Ministry of Health, Labour and Welfare
Japanese Governmental office
Ministry of Health, Labour and Welfare
NO
東海大学医学部内科学系消化器内科学
東海大学医学部付属大磯病院消化器内科
東海大学医学部付属東京病院消化器内科
東海大学医学部付属八王子病院消化器内科
帝京大学医学部内科学講座
福島県立医科大学医学部消化器内科学講座
愛媛大学大学院医学系研究科 消化器・内分泌・代謝内科学
手稲渓仁会病院消化器病センター
帝京大学医学部附属溝口病院第四内科学講座
東京慈恵会医科大学消化器・肝臓内科
国立病院機構長崎医療センター難治性疾患研究センター
福岡大学医学部消化器内科学
九州大学病院免疫膠原病感染症内科
岡山大学大学院医歯薬学総合研究科消化器・肝臓内科学
岩手医科大学内科学講座消化器内科肝臓分野
慶應義塾大学医学部内科学(消化器)
東京女子医科大学消化器内科
関西医科大学内科学第三講座
東京医科大学茨城医療センター消化器内科
新潟大学大学院医歯学総合研究科消化器内科学分野
信州大学医学部附属病院消化器内科
国立病院機構信州上田医療センター
奈良県立医科大学第三内科
山王メディカルセンター
埼玉医科大学病院消化器内科・肝臓内科
久留米大学医学部内科学講座消化器内科部門
鹿児島大学学術研究院医歯学域医学系 消化器疾患・生活習慣病学
東京医科大学臨床医学系消化器内科学分野
千葉大学大学院医学研究院消化器内科学
昭和大学藤が丘病院消化器内科
虎の門病院肝臓内科
2018 | Year | 02 | Month | 20 | Day |
Unpublished
Completed
2018 | Year | 02 | Month | 16 | Day |
2018 | Year | 02 | Month | 16 | Day |
2018 | Year | 03 | Month | 16 | Day |
2022 | Year | 03 | Month | 31 | Day |
2022 | Year | 08 | Month | 14 | Day |
2018 | Year | 02 | Month | 20 | Day |
2022 | Year | 08 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035832
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