UMIN-CTR Clinical Trial

Basic information
Public title	Influence of potentially inappropriate medications on activities of daily living in patients with osteoporotic vertebral compression fractures.
Acronym	Influence of potentially inappropriate medications on activities of daily living in patients with vertebral compression fractures.
Scientific Title	Influence of potentially inappropriate medications on activities of daily living in patients with osteoporotic vertebral compression fractures: A retrospective cohort study.
Scientific Title:Acronym	Influence of potentially inappropriate medications on activities of daily living in patients with vertebral compression fractures
Region	Japan

Condition
Condition	steoporotic vertebral compression fractures
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Potentially inappropriate medications (PIMs) are major concern in geriatric care. Osteoporotic vertebral compression fractures (OVCFs)are more common among the elderly, and more likely to receive long-term analgesics for pain and additional medications for complications, but no studies have examined the effects of PIMs on OVCFs. The purpose of our study was to clarify the association between potentially inappropriate medications (PIMs) and activities of daily living (ADL) for patients with osteoporotic vertebral compression fractures (OVCFs).
Basic objectives2	Safety
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	Patients aged 65 years or older who were hospitalized in our hospital for osteoporotic vertebral compression fracture and underwent rehabilitation through conservative treatment.
Key exclusion criteria	New multivertebral fractures, cognitive impairment, death, and data loss if serious complications occur.
Target sample size	170

Research contact person
Name of lead principal investigator	1st name Takako Middle name Last name Nagai
Organization	Nihon university hospital
Division name	Orthopedic surgery rehabilitation
Zip code	101-8309
Address	1-6 Kandasurugadai, Chiyoda-ku, Tokyo, 1018309, 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	Orthopedic surgery, rehabilitation
Zip code	101-8309
Address	1-6 Kandasurugadai, Chiyoda-ku, Tokyo, 1018309, 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
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	2019 Year 12 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	170
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	Main results already published
Date of protocol fixation	2014 Year 10 Month 01 Day
Date of IRB	2019 Year 12 Month 12 Day
Anticipated trial start date	2014 Year 10 Month 01 Day
Last follow-up date	2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	In patients treated conservatively with osteoporotic vertebral compression fractures, the PIMs group had significantly lower ADL at discharge than the non-PIMs group. Multivariate analysis showed that the PIMs group had significantly lower ADL at discharge, and the number of PIMs drugs was an independent factor for ADL at discharge.

Management information
Registered date	2019 Year 12 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=R000044405