UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040201
Receipt number 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 04:37:53

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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 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, 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

Value
https://center6.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