UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Shigeru Ohno
Organization	Yokohama City University Medical Center
Division name	Center for Rheumatic diseases
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	Akiko Suda
Organization	Yokohama City University Medical Center
Division name	Center for Rheumatic diseases
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 02 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000017130