UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The preventive effect for new vertebral fractures of zoledronic acid and denosumab combined with vitamin D in patients with rheumatoid arthritis.
Title of the study (Brief title)	EVIDENCE study
Region	Japan

Condition
Condition	Rheumatoid Arthritis Osteoporosis
Classification by specialty	Clinical immunology Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the incidence ratio of new vertebral fractures between zoledronic acid and denosumab combined with vitamin D in patients with rheumatoid arthritis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the incidence ratio of new vertebral fractures after two years
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	zoledronic acid
Interventions/Control_2	denosumab
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) Patients with rheumatoid arthritis who fulfill 2010 ACR/EULAR criteria 2) Patients fulfill the primary osteoporosis criteria in Japan 3) Aged 20 years or older 4) The patients who provided their informed consent to participate in the study
Key exclusion criteria	1) The patients with contraindication to denosumab and bisphosphonate 2) The patients who used zoledronic acid or denosumab previously 3) The patients who used teriparatide previously 4) The patients who are not included other intervention study 7) Those who are not approved to be eligible to this study by corresponding researcher
Target sample size	500

Research contact person
Name of lead principal investigator	Tadashi Okano
Organization	Osaka City University Graduate School of Medicine
Division name	Orthopaedic Surgery
Address	1-4-3 Asahi-machi, Abeno-ku, Osaka545-8585, Japan
TEL	06-6645-3851
Email	ma1sa3ru@med.osaka-cu.ac.jp

Public contact
Name of contact person	Tadashi Okano
Organization	Osaka City University Graduate School of Medicine
Division name	Orthopaedic Surgery
Address	1-4-3 Asahi-machi, Abeno-ku, Osaka545-8585, Japan
TEL	06-6645-3851
Homepage URL
Email	ma1sa3ru@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 15 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 10 Month 30 Day
Anticipated trial start date	2018 Year 01 Month 15 Day
Last follow-up date
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	2018 Year 01 Month 15 Day
Last modified on	2018 Year 01 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035188