UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010689 |
|---|---|
| Receipt number | R000012495 |
| Scientific Title | Effect of etidronate therapy on prevention of fracture, bone mineral density and bone turnover markers in osteoporotic patients with severe motor and intellectual disabilities: a randomized controlled trial |
| Date of disclosure of the study information | 2013/05/10 |
| Last modified on | 2013/05/10 16:01:49 |
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Basic information
Public title
Effect of etidronate therapy on prevention of fracture, bone mineral density and bone turnover markers in osteoporotic patients with severe motor and intellectual disabilities: a randomized controlled trial
Acronym
EOSMID
Scientific Title
Effect of etidronate therapy on prevention of fracture, bone mineral density and bone turnover markers in osteoporotic patients with severe motor and intellectual disabilities: a randomized controlled trial
Scientific Title:Acronym
EOSMID
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Geriatrics |
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Occurrence of fragile fracture, bone mineral density and bone turnover markers (serum TRAP-5b, serum NTX, serum BAP) are evaluated for oral administration of etidronate versus non-administered controls in osteoporotic patients with severe motor and intellectual disabilities. This is a randomized, open-label, multicenter trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
occurrence of fragile fracture
Key secondary outcomes
changes of bone mineral density (L2-4) and bone turnover markers (serum TRAP-5b, serum NTX, serum BAP)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients without history of fragile fracture for the past 5 years.
Repeated administration of etidronate (200mg) for 2 weeks, following a cessation for 10 weeks.
Interventions/Control_2
Patients without history of fragile fracture for the past 5 years.
Ordinary treatment.
Interventions/Control_3
Patients with history of fragile fracture for the past 5 years.
Repeated administration of etidronate (200mg) for 2 weeks, following a cessation for 10 weeks.
Interventions/Control_4
Patients with history of fragile fracture for the past 5 years.
Ordinary treatment.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with osteoporosis (BMD: less than 70% of YAM)
2. Patients with severe motor and intellectual disabilities (Ohshima's classification: 1,2,3,4)
3. Patients with informed of consent obtained from a parent or other family member.
Key exclusion criteria
1. Patients with other diseases presenting low BMD
2. Patients with GERD
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigenori Yamamoto |
Organization
NHO Shimoshizu National Hospital
Division name
Pediatrics
Zip code
Address
Chiba Yotsukaido Shikawatashi 934-5
TEL
043-422-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigenori Yamamoto |
Organization
NHO Shimoshizu National Hospital
Division name
Pediatrics
Zip code
Address
Chiba, Yotsukaido, Shikawatashi 934-5
TEL
043-422-2511
Homepage URL
http://www.hosp.go.jp/~simosizu/
syamamoto3@nifty.com
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
国立病院機構下志津病院（千葉県）、国立病院機構愛媛病院（愛媛県）、国立病院機構柳井医療センター（山口県）、国立病院機構青森病院（青森県）、国立病院機構岩手病院（岩手県）、国立病院機構南京都病院（京都府）、国立病院機構高知病院（高知県）、国立病院機構西別府病院（大分県）、国立病院機構千葉東病院（千葉県）、国立病院機構宮崎病院（宮崎県）、国立病院機構香川小児病院（香川県）、国立病院機構医王病院（石川県）、国立病院機構新潟病院（新潟県）、国立病院機構山口宇部医療センター（山口県）、国立病院機構西群馬病院（群馬県）、国立病院機構広島西医療センター（広島県）、国立病院機構名古屋医療センター（愛知県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2009 | Year | 12 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 10 | Day |
Last modified on
| 2013 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012495
