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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000467
Receipt No. R000000567
Scientific Title Cluster randomised controlled trial of hip protectors for the prevention of hip fractures among women in nursing homes
Date of disclosure of the study information 2006/08/15
Last modified on 2012/11/28

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Basic information
Public title Cluster randomised controlled trial of hip protectors for the prevention of hip fractures among women in nursing homes
Acronym Hip protector trial
Scientific Title Cluster randomised controlled trial of hip protectors for the prevention of hip fractures among women in nursing homes
Scientific Title:Acronym Hip protector trial
Region
Japan

Condition
Condition Osteoporosis with risk factors for falls and hip fractures
Classification by specialty
Endocrinology and Metabolism Geriatrics Orthopedics
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess whether the use of hip protectors would prevent hip fractures among women with risk factors for falls and hip fractures by cluster randomization. Interaction between the use of hip protectors and risk factors will be examined.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the number of hip fractures
Key secondary outcomes the number of fractures on extremities, the rate of falls, compliance

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 use of hip protectors
Interventions/Control_2 observation
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
65 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria elderly women aged 65 years or older, who are at high risk for falls and hip fractures in nursing homes
Key exclusion criteria bedridden, those who had bilateral hip fractures previously
Target sample size 750

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Koike
Organization Osaka City University Medical School
Division name Rheumatosurgery
Zip code
Address Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL 06-6645-3851
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Koike
Organization Osaka City University Medical School
Division name Rheumatosurgery
Zip code
Address Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL 06-6645-3851
Homepage URL
Email tatsuya@med.osaka-cu.ac.jp

Sponsor
Institute Department of Orthopaedic Surgery, Osaka City University Medical School
Institute
Department

Funding Source
Organization the MInistry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Orthopaedic Surgery, Shinshu University School of Medicine
Name of secondary funder(s) Research Society for Metabolic Bone Diseases

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

Other administrative information
Date of disclosure of the study information
2006 Year 08 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.springerlink.com/content/556p5163504810hw/fulltext.html
Number of participants that the trial has enrolled
Results
In our cluster randomised controlled trial for efficacy of hip protector with 672 ambulatory elderly women, a hip protector was more effective for prevention of hip fractures in residents with fall history (n=202; HR, 0.375; 95%CI, 0.14-0.98; P=0.05) and BMI &#8804;19.0 (n=206; HR, 0.37; 95%CI, 0.14-0.95; P=0.04) by a Cox proportional hazards regression model. 
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
2003 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 01 Month 01 Day
Last follow-up date
2006 Year 03 Month 01 Day
Date of closure to data entry
2006 Year 04 Month 01 Day
Date trial data considered complete
2006 Year 05 Month 01 Day
Date analysis concluded
2006 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 08 Month 11 Day
Last modified on
2012 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000567

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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