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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010689
Receipt No. 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

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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
Email

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/
Email syamamoto3@nifty.com

Sponsor
Institute National Hospital Organization
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012495

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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