UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042880 |
|---|---|
| Receipt number | R000048943 |
| Scientific Title | Association among Geriatric Nutrition Risk Index and functional prognosis in elderly patients with osteoporotic vertebral compression fractures: a retrospective cohort study |
| Date of disclosure of the study information | 2020/12/31 |
| Last modified on | 2020/12/31 06:31:34 |
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Basic information
Public title
Association among Geriatric Nutrition Risk Index and functional prognosis in elderly patients with osteoporotic vertebral compression fractures
Acronym
Association among Geriatric Nutrition Risk Index and functional prognosis in elderly patients with osteoporotic vertebral compression fractures
Scientific Title
Association among Geriatric Nutrition Risk Index and functional prognosis in elderly patients with osteoporotic vertebral compression fractures: a retrospective cohort study
Scientific Title:Acronym
Association among Geriatric Nutrition Risk Index and functional prognosis in elderly patients with osteoporotic vertebral compression fractures: a retrospective cohort study
Region
| Japan |
Condition
Condition
osteoporotic vertebral compression fractures
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to retrospectively investigate the basic information on conservative treatment of patients with osteoporotic vertebral compression fractures (Sex, age, height, weight, fracture classification, serum albumin level, complications), the Barthel index (BI) as an ADL index, the Geriatric Nutritional Risk Index (GNRI) as a nutritional index, the Japanese Orthopaedic Association Criteria for the Treatment of Low Back Pain (JOA score), and the presence or absence of falls, to identify factors influencing functional prognosis and to verify the optimal intervention method for preventing falls.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Barthel index gain
Key secondary outcomes
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Conservative treatment with a corset in a patient with osteoporotic vertebral compression fracture aged 65 years or older
Key exclusion criteria
Blast transformation, multiple fractures, MMSE under 23, missing data
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | |
| Last name | Nagai |
Organization
Nihon University Hospital
Division name
Orthpedic surgery
Zip code
1018309
Address
1 -6 Kandasurugadai, Chiyoda-ku, Tokyo
TEL
0332931711
ntnyf092@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takako |
| Middle name | |
| Last name | Nagai |
Organization
Nihon University Hospital
Division name
Orthpedic surgery
Zip code
1018309
Address
1 -6 Kandasurugadai, Chiyoda-ku, Tokyo
TEL
0332931711
Homepage URL
ntnyf092@yahoo.co.jp
Sponsor or person
Institute
Nihon University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nihon University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University hospital
Address
1 -6 Kandasurugadai, Chiyoda-ku, Tokyo
Tel
0332931711
ntnyf092@yahoo.co.jp
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
| 2020 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
187
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
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
There were 68 malnourished patients and 119 well nourished patients. Univariate analysis revealed significant differences in body mass index (BMI), serum albumin, body mineral density (BMD), final BI, BI gain, JOA score, and refall rate among the subjects. In the Spearman rank correlation coefficient, there were positive correlations between GNRI and serum albumin, BMD, BI gain, and JOA score, and negative correlations with refall rate. As a result of multiple regression analysis and logistic regression analysis, GNRI was extracted as a factor related to BI gain and re-fall.
Management information
Registered date
| 2020 | Year | 12 | Month | 31 | Day |
Last modified on
| 2020 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048943
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
