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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-UMIN000010615 |
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Date of registration:
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30/04/2013 |
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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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Clinical study on efficacy of alendronate infusion for pediatric osteogenesis imperfecta (including severe form)
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Scientific title:
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Clinical study on efficacy of alendronate infusion for pediatric osteogenesis imperfecta (including severe form) - Alendronate infusion for osteogenesis imperfecta |
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Date of first enrolment:
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2013/04/30 |
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Target sample size:
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10 |
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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=R000012407 |
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Study type:
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Interventional |
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Study design:
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Single arm 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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Ikuma
Fujiwara |
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Address:
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1-1 Seiryo-machi, Aoba-ku, Sendai
022-0872
Japan |
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Telephone:
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022-717-7287 |
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Email:
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ifujiwara-endo@umin.ac.jp |
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Affiliation:
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Tohoku University School of Medicine Department of Pediatrics |
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Name:
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Ikuma
Fujiwara |
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Address:
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1-1 Seiryo-machi, Aoba-ku, Sendai
Japan |
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Telephone:
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022-717-7287 |
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Email:
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ifujiwara-endo@umin.ac.jp |
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Affiliation:
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Tohoku University School of Medicine Department of Pediatrics |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: -Patients with the following diseases which show fracture easily: Juvenile osteoporosis, hypophosphatasia, Ehlers-Danlos syndrome, Osteoporosis-pseudoglioma syndrome, Bruck syndrome. -Patients with osteogenesis imperfecta who falls under any of the following conditions shall be excluded: 1) Patients previously treated with any medical treatment including bisphosphonates 2) Patients with severe renal dysfunction 3) Patients with severe brain complication such as intracranial hemorrhage 4) Patients with congenital heart disease
Age minimum:
Not applicable
Age maximum:
15years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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osteogenesis imperfecta
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Intervention(s)
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Eighteen micrograms (2 ml)/kg of alendronate will be infused in 1 hour every 4 weeks. The study duration is 6 months. When the patient's BMD reaches to the normal range for age, treatment with alendronate will be finished. When the patient's BMD does not reach to the normal range for age, alendronate will be continued for another 6 months.
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Primary Outcome(s)
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Bone mineral density (BMD)
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Secondary Outcome(s)
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Frequency of fracture
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Source(s) of Monetary Support
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None
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Ethics review
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Status: YES
Approval date: 26/03/2013
Contact:
rinri-2@proj.med.tohoku.ac.jp
Tohoku University Hospital IRB
022-717-7146
rinri-2@proj.med.tohoku.ac.jp
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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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28/02/2018 |
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URL:
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