UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000543 |
|---|---|
| Receipt number | 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 18:47:05 |
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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
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
spine@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000634
