UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Treatment strategy of minodronate in osteoporotic patients with rheumatoid arthritis
Title of the study (Brief title)	Effectiveness of minodronate in osteoporotic patients with rheumatoid arthritis
Region	Japan

Condition
Condition	Osteoprotic patients with rheumatoid arthritis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To build preliminary data of effectiveness and safety for 2 different treatments; 1) minodoronate alone or 2) minodronate plus active vitamin D in osteoporotic patients with rheumatoid arthritis
Basic objectives2	Others
Basic objectives -Others	N/A
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Value changes of bone mineral density (lumber as well as bilateral proximal hip) before treatment and at 24 months after treatment
Key secondary outcomes	Frequencies of adverse effects (at 6, 12, and 24 months after treatment) Value chanes of the following at 6, 12, and 24 months after treatment 1. Bone mineral density (lumber as well as bilateral proximal hip) values 2. Values of bone turnover markers 3. Values of serum vitamin D 4. Values of serum PTH

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
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	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The selection criteria is based on which treatment each patient wants to take
Interventions/Control_2	Minodronate group: oral intake 50mg per month
Interventions/Control_3	Minodronate plus active vitamin D group: oral intake 50mg minodronate per month and eldecalcitol 0.75ug per day after breakfast
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Rheumatoid arthritis compliactated with steoporosis, aged over 20. 2. The patients who desire to take the above treatment 3. The patients who agree to perform this study after sufficient informed consent
Key exclusion criteria	1. The patients who are allergic to minodronate or eldecalcitol 2. The patients with hypercalcemia before treatment 3. The patients whom we judge as inappropriate
Target sample size	140

Research contact person
Name of lead principal investigator	Yukio Nakamura
Organization	Shinshu University School of Medicine
Division name	Department of Orthopaedic Surgery
Address	Asahi3-1-1, Matsumoto 3908621, Japan
TEL	0263372659
Email	yxn14@aol.jp

Public contact
Name of contact person	Yukio Nakamura
Organization	Shinshu University School of Medicine
Division name	Department of Orthopaedic Surgery
Address	Asahi3-1-1, Matsumoto 3908621, Japan
TEL	0263372659
Homepage URL	https://shinshu.bvits.com/rinri/Apply/show.aspx?TYPE=0&ID=2426
Email	yxn14@aol.jp

Sponsor
Institute	Department of Orthopaedic Surgery Shinshu University School of Medicine
Institute
Department

Funding Source
Organization	Ono Pharmaceutical Company
Organization
Division
Category of Funding Organization	Profit organization
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

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 09 Day
Anticipated trial start date	2016 Year 05 Month 10 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 19 Day
Last modified on	2019 Year 02 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025762