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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-UMIN000002474 |
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Date of registration:
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01/10/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Preventive effect of vit K, vit D and, risedronate on 3-dimensional trabecular microstructure in patients with IgA nephropathy on glucocorticoid treatment
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Scientific title:
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Preventive effect of vit K, vit D and, risedronate on 3-dimensional trabecular microstructure in patients with IgA nephropathy on glucocorticoid treatment - The Preventive Risedronate Intervention for those Undergoing Steroid therapy with IgA nephropathy (PRIUS-IgA Study ) |
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Date of first enrolment:
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2007/01/01 |
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Target sample size:
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30 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003035 |
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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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Not applicable
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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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Yoshitaka Isaka |
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Address:
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2-15 Yamada-oka Suita, Osaka, 565-0871, Japan
Japan |
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Telephone:
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06-6879-3857 |
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Email:
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Affiliation:
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Osaka University Hospital Nephrology |
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Name:
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Yoshitaka Isaka |
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Address:
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2-15 Yamada-oka Suita, Osaka, 565-0871, Japan
Japan |
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Telephone:
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06-6879-3857 |
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Email:
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isaka@kid.med.osaka-u.ac.jp |
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Affiliation:
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Osaka University Hospital Nephrology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1, women who hope for future pregnancy 2, patients who already have had osteopenia or osteoporosis 3, patients with chronic kidney disease stage 3-5 4, postmenopausal women 5, patients with any prior history of glucocorticoid therapy
Age minimum:
18years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Glucocorticoid induced osteoporosis in patients with IgA nephropathy
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Intervention(s)
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Menatetrenone 45mg/day for 6 months
Calcitriol 0.5 microgram/day for 6 months
Risedronate 17.5mg/week for 6 months
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Primary Outcome(s)
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Changes in 3-dimensional trabecular bone structure at 6-month after the start of intervention
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Secondary Outcome(s)
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Changes in bone turnover markers and bone mineral density
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Source(s) of Monetary Support
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Eisai
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Ethics review
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Status: YES
Approval date:
Contact:
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