UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015794
Receipt number R000018380
Scientific Title 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 )
Date of disclosure of the study information 2014/12/10
Last modified on 2018/03/12 11:03:33

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Basic information

Public title

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 )

Acronym

RISOTTO
(sodium RISedrOnate for sTeroid induced osTeOporosis with rheumatoid arthritis)

Scientific Title

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 )

Scientific Title:Acronym

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

1st name
Middle name
Last name Tatsuya Atsumi

Organization

Hokkaido University Graduate School of Medicine

Division name

Division of rheumatology, endcrinology and nephrology

Zip code


Address

N15, W7, Kita-ku, Sapporo, Hokkaido, Japan

TEL

011-706-5915

Email

at3tat@med.hokudai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Nao Horie

Organization

Hokkaido University Hospital

Division name

Clinical Research and Medical Innovation Center

Zip code


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 or person

Institute

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

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2014 Year 12 Month 10 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

No longer recruiting

Date of protocol fixation

2014 Year 12 Month 01 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018380


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name