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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000015794 |
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Date of registration:
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10/12/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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 )
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Scientific title:
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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 ) - RISOTTO (sodium RISedrOnate for sTeroid induced osTeOporosis with rheumatoid arthritis) |
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Date of first enrolment:
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2014/12/15 |
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Target sample size:
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165 |
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Recruitment status: |
Complete: follow-up continuing |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018380 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Phase IV
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Countries of recruitment
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Japan
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Contacts
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Name:
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Tatsuya Atsumi |
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Address:
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N15, W7, Kita-ku, Sapporo, Hokkaido, Japan
Japan |
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Telephone:
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011-706-5915 |
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Email:
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at3tat@med.hokudai.ac.jp |
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Affiliation:
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Hokkaido University Graduate School of Medicine Division of rheumatology, endcrinology and nephrology |
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Name:
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Nao Horie |
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Address:
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N14, W5, Kita-ku, Sapporo, Hokkaido, Japan
Japan |
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Telephone:
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011-706-7735 |
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Email:
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nhorie@med.hokudai.ac.jp |
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Affiliation:
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Hokkaido University Hospital Clinical Research and Medical Innovation Center |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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osteoporosis, rheumatoid arthritis
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Intervention(s)
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monthly risedronate sodium 75mg for 6 months
monthly placebo for 6 months
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Primary Outcome(s)
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Percentage change from baseline in the bone mineral density of lumbar spine (L2-4) at 6 months
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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Eisai Co, Ltd
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/01/2018 |
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URL:
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