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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000543
Receipt No. R000000634
Scientific Title Elucidation of prognostic factor of osteoporotic vertebral fracture and establishment of its effective and efficient treatment- prospective, multicenter study -
Date of disclosure of the study information 2006/12/11
Last modified on 2013/06/25

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Basic information
Public title Elucidation of prognostic factor of osteoporotic vertebral fracture and establishment of its effective and efficient treatment- prospective, multicenter study -
Acronym Elucidation of prognostic factor of osteoporotic vertebral fracture
Scientific Title Elucidation of prognostic factor of osteoporotic vertebral fracture and establishment of its effective and efficient treatment- prospective, multicenter study -
Scientific Title:Acronym Elucidation of prognostic factor of osteoporotic vertebral fracture
Region
Japan

Condition
Condition osteoporotic vertebral fracture
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate prognostic factor of osteoporotic vertebral fracture
Basic objectives2 Others
Basic objectives -Others prognosis
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes QOL, pain and incidence of intravertebral pseudoarthrosis at 6months
Key secondary outcomes mortality at 6 months

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Men and women aged 65 years or older with fresh osteoporotic vertebral fracture
Key exclusion criteria younger than 65 years, pathologic fracture caused by malignant disease
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Nakamura
Organization Osaka City General Hospital
Division name Department of Orthopaedic Surgery
Zip code
Address 2-13-22 Miyakojimahondori Miyakojima-ku, Osaka
TEL 06-6929-1221
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hidetomi Terai
Organization Osaka City University Graduate School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address 1-4-3 Asahi-machi Abeno-ku, Osaka
TEL 06-6645-3851
Homepage URL
Email spine@med.osaka-cu.ac.jp

Sponsor
Institute Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2006 Year 12 Month 11 Day

Related information
URL releasing protocol
Publication of results 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
2005 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2005 Year 09 Month 01 Day
Last follow-up date
2008 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information (Study design) Prospective, multi-center study
(Sampling) Consecutive sampling
(Predictors) Physical, habitual, psychological, social and therapeutic factors
(Outcomes)QOL, pain, incidence of intravertebral pseudoarthrosis and mortality at 6months

Management information
Registered date
2006 Year 12 Month 08 Day
Last modified on
2013 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000634

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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