UMIN-CTR Clinical Trial

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
Email	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
Email	ntnyf092@yahoo.co.jp

Sponsor
Institute	Nihon University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048943