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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010615
Receipt No. R000012407
Scientific Title Clinical study on efficacy of alendronate infusion for pediatric osteogenesis imperfecta (including severe form)
Date of disclosure of the study information 2013/04/30
Last modified on 2019/11/04

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Basic information
Public title Clinical study on efficacy of alendronate infusion for pediatric osteogenesis imperfecta (including severe form)
Acronym Alendronate infusion for osteogenesis imperfecta
Scientific Title Clinical study on efficacy of alendronate infusion for pediatric osteogenesis imperfecta (including severe form)
Scientific Title:Acronym Alendronate infusion for osteogenesis imperfecta
Region
Japan

Condition
Condition osteogenesis imperfecta
Classification by specialty
Pediatrics Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of alendronate infusion for pediatric osteogenesis imperfecta
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Bone mineral density (BMD)
Key secondary outcomes Frequency of fracture

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2
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

Not applicable
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria -Informed consent obtained from each subject's parent or the subject's legally acceptable representative before any study-related activities.
-Patients clinically diagnosed as osteogenesis imperfecta with all the types according to Sillence phenotypes (I - IV).
Key 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
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Ikuma
Middle name
Last name Fujiwara
Organization Tohoku University School of Medicine
Division name Department of Pediatrics
Zip code 022-0872
Address 1-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7287
Email ifujiwara-endo@umin.ac.jp

Public contact
Name of contact person
1st name Ikuma
Middle name
Last name Fujiwara
Organization Tohoku University School of Medicine
Division name Department of Pediatrics
Zip code 022-0872
Address 1-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7287
Homepage URL
Email ifujiwara-endo@umin.ac.jp

Sponsor
Institute Tohoku University School of Medicine, Department of Pediatrics
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tohoku University Hospital IRB
Address 1-1 Seiryo-machi, Aoba-ku, Sendai
Tel 022-717-7146
Email rinri-2@proj.med.tohoku.ac.jp

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 東北大学病院(宮城県)

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 30 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
2013 Year 04 Month 30 Day
Date of IRB
2013 Year 03 Month 26 Day
Anticipated trial start date
2013 Year 04 Month 30 Day
Last follow-up date
2018 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 04 Month 30 Day
Last modified on
2019 Year 11 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012407

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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