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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040201
Receipt No. R000045843
Scientific Title Relationship between potentially inappropriate medications and functional prognosis in elderly patients with distal radius fracture: A retrospective cohort study.
Date of disclosure of the study information 2020/04/20
Last modified on 2020/04/20

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Basic information
Public title Relationship between potentially inappropriate medications and functional prognosis in elderly patients with distal radius fracture: A retrospective cohort study.

Acronym Relationship between potentially inappropriate medications and functional prognosis in elderly patients with distal radius fracture

Scientific Title Relationship between potentially inappropriate medications and functional prognosis in elderly patients with distal radius fracture: A retrospective cohort study.

Scientific Title:Acronym Relationship between potentially inappropriate medications and functional prognosis in elderly patients with distal radius fracture

Region
Japan

Condition
Condition Distal radius fracture
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the association of PIMs with ADL and the rate of postoperative repeat falls in elderly patients with distal radius fractures.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes rate of subsequent falls
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 Patients aged 65 years or older who underwent surgery for distal radius fracture who were followed up for 1 year after surgery
Key exclusion criteria Unambulatory cases, fatal cases, and data loss cases before injury
Target sample size 253

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,Japan
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,Japan
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, Japan
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 04 Month 20 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 253
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
2019 Year 04 Month 09 Day
Anticipated trial start date
2014 Year 10 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Of the 253 patients, 107 (42.3%) were treated with PIMs and 146 (57.7%) were not treated with PIMs. Age, sex, CCI, fracture type, and Mayo wrist score were used to calculate PS. After PS matching, there were 107 patients in the PIMs group and 84 patients in the non-PIMs group. Prior to matching, significant differences were observed in serum albumin level, CCI, fracture type, length of hospital stay, and fall rate (p < 0.05). Univariate analysis after PS matching showed significant differences in CCI (P < 0.05), number of drugs (p < 0.01), BI efficiency (p < 0.01), and fall over rate (p < 0.01). Multiple regression analysis using BI efficiency as the dependent variable and PIMs as the independent variable showed that PIMs were independently associated with BI efficiency (p < 0.05, beta = -0.181). In logistic regression analysis with or without falls as the dependent variable, PIMs were independently associated with or without falls (p < 0.01). Multivariate analysis revealed no multiple collinearity of independent variables. (VIF < 10)

Management information
Registered date
2020 Year 04 Month 20 Day
Last modified on
2020 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045843

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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