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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012193
Receipt No. R000014251
Scientific Title Efficacy of the anti-RANKL human antibody (Denosumab) versus Bisphosphonate for the treatment of osteoporosis in patients with primary biliary cirrhosis
Date of disclosure of the study information 2013/11/01
Last modified on 2016/01/04

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Basic information
Public title Efficacy of the anti-RANKL human antibody (Denosumab) versus Bisphosphonate for the treatment of osteoporosis in patients with primary biliary cirrhosis
Acronym Denosumab versus Bisphosphonate for osteoporosis in patients with PBC
Scientific Title Efficacy of the anti-RANKL human antibody (Denosumab) versus Bisphosphonate for the treatment of osteoporosis in patients with primary biliary cirrhosis
Scientific Title:Acronym Denosumab versus Bisphosphonate for osteoporosis in patients with PBC
Region
Japan

Condition
Condition Osteoporosis in biopsy-proven primary biliary cirrhosis patients pretreated with bisphosphonate
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of denosumab on prevention of osteoporosis with primary biliary cirrhosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Percent change of bone mineral density (BMD) in 6 months and 12 months
Key secondary outcomes 1)Percent change 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Discontinue the administration of aredoron acid, risedronic acid, and minodronic acid. Then, 60mg of denosumab will be subcutaneously injected every 6 months for 12 months. All patients will take activated vitamin D. In the case of hypocalcemia, calcium will be administrated appropriately.
Interventions/Control_2 Continue the administration of bisphosphonate as heretofore. All patients will take activated vitamin D.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Osteoporosis in biopsy-proven primary biliary cirrhosis pretreated with bisphosphonate
2)Patients given written consent after being provided with sufficient explanation about participation in this clinical trial
Key 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 with the possibility of atypical fracture
8)severe skin infection
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Ikejima
Organization Juntendo University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email ikejima@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Reiko Yaginuma
Organization Juntendo University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email yagirei@juntendo.ac.jp

Sponsor
Institute Juntendo University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 順天堂大学医学部附属順天堂医院

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 01 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 Completed
Date of protocol fixation
2013 Year 10 Month 18 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 01 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
2013 Year 11 Month 01 Day
Last modified on
2016 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014251

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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