UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010615 |
|---|---|
| Receipt number | 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 11:47:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
ifujiwara-endo@umin.ac.jp
Sponsor or person
Institute
Tohoku University School of Medicine, Department of Pediatrics
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012407
