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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014737
Receipt No. R000017130
Scientific Title The effects of denosumab compared with oral bisphosphonates (BP) in patients with RA complicated with osteoporosis on the progression of structural damage, BMD and disease activity.
Date of disclosure of the study information 2014/08/01
Last modified on 2016/08/03

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Basic information
Public title The effects of denosumab compared with oral bisphosphonates (BP) in patients with RA complicated with osteoporosis on the progression of structural damage, BMD and disease activity.
Acronym Two Birds trial
Scientific Title The effects of denosumab compared with oral bisphosphonates (BP) in patients with RA complicated with osteoporosis on the progression of structural damage, BMD and disease activity.
Scientific Title:Acronym Two Birds trial
Region
Japan

Condition
Condition rheumatoid arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the effects of denosumab compared with BP on the progression of structural damage, BMD and disease activity in RA patients with RA
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes The change in mTSS from baseline to 52 weeks
Key secondary outcomes The changes from baseline to 52 weeks in DAS28,SDAI,CDAI and BMD

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 Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Denosumab group: Denosumab 60mg is administered by subcutaneous injections every 6 months (at baseline, at 6 months and at 12 months). All patients are to take vitamin D.
Interventions/Control_2 BP group: Patients take BP continuously. All patients are to take 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
50 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria (1) The presence of RA, as classified according to the ACR 2010 criteria
(2) Age: from 50 years old to less than 90 years old
(3) BP for more than 6 months
(4) Each patients gave written informed concent.
Key exclusion criteria (1) Use of a biologics agent for RA within 8 weeks before trial
(2) Use of JAK inhibitor
(3) Gulcocorticoid dose >10mg/day (prednisone or equivalent)
(4) Patients whom the doctor judged unsuitable for participation from medical reason.
Target sample size 286

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Ohno
Organization Yokohama City University Medical Center
Division name Center for Rheumatic diseases
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Email ohno@urahp.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Suda
Organization Yokohama City University Medical Center
Division name Center for Rheumatic diseases
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email sakiko@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 横浜市立大学附属市民総合医療センター(神奈川県)
横浜市立大学附属病院(神奈川県)
横浜南共済病院(神奈川県)
みなと赤十字病院(神奈川県)
横浜医療センター(神奈川県)
大和市立病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2014 Year 08 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 Terminated
Date of protocol fixation
2014 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 08 Month 01 Day
Last modified on
2016 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017130

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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