UMIN-CTR Clinical Trial

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