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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-UMIN000022364 |
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Date of registration:
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20/05/2016 |
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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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Treatment strategy of minodronate in osteoporotic patients with rheumatoid arthritis
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Scientific title:
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Treatment strategy of minodronate in osteoporotic patients with rheumatoid arthritis - Effectiveness of minodronate in osteoporotic patients with rheumatoid arthritis |
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Date of first enrolment:
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2016/05/10 |
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Target sample size:
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140 |
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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=R000025762 |
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Study type:
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Interventional |
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Study design:
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Parallel Non-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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Yukio Nakamura |
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Address:
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Asahi3-1-1, Matsumoto 3908621, Japan
Japan |
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Telephone:
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0263372659 |
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Email:
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yxn14@aol.jp |
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Affiliation:
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Shinshu University School of Medicine Department of Orthopaedic Surgery |
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Name:
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Yukio Nakamura |
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Address:
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Asahi3-1-1, Matsumoto 3908621, Japan
Japan |
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Telephone:
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0263372659 |
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Email:
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yxn14@aol.jp |
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Affiliation:
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Shinshu University School of Medicine Department of Orthopaedic Surgery |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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
Age minimum:
50years-old
Age maximum:
100years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Osteoprotic patients with rheumatoid arthritis
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Intervention(s)
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The selection criteria is based on which treatment each patient wants to take
Minodronate group: oral intake 50mg per month
Minodronate plus active vitamin D group: oral intake 50mg minodronate per month and eldecalcitol 0.75ug per day after breakfast
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Primary Outcome(s)
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Value changes of bone mineral density (lumber as well as bilateral proximal hip) before treatment and at 24 months after treatment
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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Ono Pharmaceutical Company
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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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31/03/2019 |
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URL:
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