UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038936 |
|---|---|
| Receipt number | R000044405 |
| Scientific Title | Influence of potentially inappropriate medications on activities of daily living in patients with osteoporotic vertebral compression fractures: A retrospective cohort study. |
| Date of disclosure of the study information | 2019/12/20 |
| Last modified on | 2020/04/20 04:43:47 |
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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
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
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
Tel
0332931711
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044405
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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