UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of monthly sodium risedronate for the treatment of corticosteroid induced osteoporosis in patients with rheumatoid arthritis (multicenter, double-blind, randomized, placebo-controlled, parallel-group study )
Title of the study (Brief title)	RISOTTO (sodium RISedrOnate for sTeroid induced osTeOporosis with rheumatoid arthritis)
Region	Japan

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

Objectives
Narrative objectives1	To investigate the efficacy of monthly sodium risedronate for the treatment of coricosteroid induced osteoporosis in patients with rheumatoid arthritis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase IV

Assessment
Primary outcomes	Percentage change from baseline in the bone mineral density of lumbar spine (L2-4) at 6 months
Key secondary outcomes	Percentage change from baseline in the bone mineral density of femoral neck and total hip at 6 months Incidence of vertebral fractures at 6 months Change from baseline in bone metabolic markers such as TRACP-5b and BAP at 6 months Change from baseline in disease activity score 28 (DAS28) at 6 months

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation	YES
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	monthly risedronate sodium 75mg for 6 months
Interventions/Control_2	monthly placebo for 6 months
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	Rheumatoid arthritis patients with osoteoporosis receiving corticosteroid for more than 3 months. In addition, patients who have more than 3 in the risk factor scores in Japanese guideline for the management and treatment in patients with corticosteroid induced osteoporosis.
Key exclusion criteria	Patients who received drugs for osteoporosis within 2 months at inclusion of the study except alphacalcidol and calcitriol Patients who had received bisphosphonates Patients who had undergone the operation of lumbar spine Patients who have a severe decayed tooth to be treated Patients who are considered to be contraindicated for bisphosphonates Patients who are thought to be inappropriate for this study by physicians
Target sample size	165

Research contact person
Name of lead principal investigator	Tatsuya Atsumi
Organization	Hokkaido University Graduate School of Medicine
Division name	Division of rheumatology, endcrinology and nephrology
Address	N15, W7, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-5915
Email	at3tat@med.hokudai.ac.jp

Public contact
Name of contact person	Nao Horie
Organization	Hokkaido University Hospital
Division name	Clinical Research and Medical Innovation Center
Address	N14, W5, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-7735
Homepage URL	http://trctca.huhp.hokudai.ac.jp/
Email	nhorie@med.hokudai.ac.jp

Sponsor
Institute	Division of rheumatology, endcrinology and nephrology, Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Eisai Co, Ltd
Organization
Division
Category of Funding Organization	Profit organization
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	2014 Year 12 Month 10 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 12 Month 01 Day
Anticipated trial start date	2014 Year 12 Month 15 Day
Last follow-up date	2018 Year 01 Month 31 Day
Date of closure to data entry	2018 Year 04 Month 20 Day
Date trial data considered complete	2018 Year 04 Month 30 Day
Date analysis concluded	2018 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 11 Month 30 Day
Last modified on	2018 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018380