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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031384
Receipt No. 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 2018/04/26

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Basic information
Public title Efficacy and safety of Denosumab treatment for osteoporosis in patients with primary biliary cholangitis; a randomized controlled trial with zoledronic acid (DELTA Study)
Acronym Efficacy and safety of Denosumab treatment for osteoporosis in patients with primary biliary cholangitis; a randomized controlled trial with zoledronic acid (DELTA Study)
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)
Scientific Title:Acronym Efficacy and safety of Denosumab treatment for osteoporosis in patients with primary biliary cholangitis; a randomized controlled trial with zoledronic acid (DELTA Study)
Region
Japan

Condition
Condition PBC patients with osteoporosis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in bone density after 12 months treatment (Lumbar spine and proximal femur)
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Denosumab group
(60 mg Denosumab is administered subcutaneously every 6 month)
Interventions/Control_2 Zoledronic acid group
(5 mg Zoledronic acid is administered intravenously every 12 month)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
89 years-old >
Gender Male and Female
Key inclusion criteria 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
Key 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
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Arase
Organization Tokai University School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address shimokasuya 143, Isehara, Kanagawa, Japan
TEL 0463-93-1121
Email arase@tokai-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitaka Arase
Organization Tokai University Oiso Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address Gakkyo 21-1, Oisotyo, Nakagun, Kanagawa, Japan
TEL 0463-72-3211
Homepage URL
Email arase@tokai-u.jp

Sponsor
Institute Tokai University School of Medicine
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Ministry of Health, Labour and Welfare
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 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

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 02 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 20 Day
Last modified on
2018 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035832

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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