UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062086 |
|---|---|
| Receipt number | R000071036 |
| Scientific Title | Establishment of a Novel Secondary Fracture Prevention Framework Using a Medication Adherence Prediction Scoring System |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/06/28 17:26:57 |
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Basic information
Public title
Establishment of a Novel Secondary Fracture Prevention Framework Using a Medication Adherence Prediction Scoring System
Acronym
Establishment of a Novel Secondary Fracture Prevention Framework Using a Medication Adherence Prediction Scoring System
Scientific Title
Establishment of a Novel Secondary Fracture Prevention Framework Using a Medication Adherence Prediction Scoring System
Scientific Title:Acronym
Establishment of a Novel Secondary Fracture Prevention Framework Using a Medication Adherence Prediction Scoring System
Region
| Japan |
Condition
Condition
Femur Fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to identify the factors influencing medication adherence for each specific drug.
In addition to patient background information, we will also investigate biological and functional factors that determine treatment adherence using saliva-derived biomarkers and body composition assessments (InBody).
Based on the identified factors, we will develop a drug-specific medication adherence prediction scoring system for use in drug selection.
Basic objectives2
Others
Basic objectives -Others
The objectives of this study are; (1) to evaluate treatment adherence rates six months and one year after the initial fracture; (2) to identify factors influencing treatment adherence based on patients' clinical conditions, post-discharge outcomes, and socioeconomic background; and (3) to develop a predictive model for medication adherence using the information obtained in (2).
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Medication adherence rates six months and one year after the initial fracture
Factors affecting medication adherence
Key secondary outcomes
Follow-up rates six months and one year after the initial fracture
Factors affecting follow-up rates
Differences in medication adherence rates with and without pharmacist intervention
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with femoral fractures
Individuals who provided consent to participate in this study by signing a consent form
Aged 18 years or older
Key exclusion criteria
1.Individuals from whom written consent could not be obtained (for retrospective medical record reviews, this includes cases where the subject or their representative refused to allow the use of their information for research purposes)
2.Other patients deemed inappropriate by the attending physician
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Yagi |
Organization
Hamamatsu University School of Medicine, University Hospital
Division name
Department of hospital pharmacy
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-Ku, Hamamatsu, 431-3192, Japan.
TEL
0534352767
yagi5922@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Sumika |
| Middle name | |
| Last name | Osa |
Organization
Hamamatsu University School of Medicine, University Hospital
Division name
Department of hospital pharmacy
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-Ku, Hamamatsu, 431-3192, Japan.
TEL
0534352767
Homepage URL
sumika.osa@gmail.com
Sponsor or person
Institute
Hmamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsy University of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Chuo-Ku, Hamamatsu, 431-3192, Japan.
Tel
0534352111
rinri@hama-med.ac.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
| 2026 | Year | 07 | Month | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Items to Be Collected as Data
Subject Background: Name, age, gender, diagnosis, surgical procedure, medical history, lifestyle history, care level, history of adverse effects, concomitant medications, medication status (information related to adherence, number of remaining pills, etc.), medication management status (administrator, use of unit-dose packaging, etc.), performance status, post-discharge outcomes, number and types of medications taken, etc.
Rehabilitation assessment items: grip strength, FIM (Functional Independence Measure), MOCA-J
Osteoporosis assessment items: bone density, etc.
Physical findings: height, weight, body surface area, BMI, blood pressure, pulse, body temperature
Laboratory tests: Hematological tests (white blood cell count, hemoglobin level, platelet count, neutrophil count, lymphocyte count, etc.), biochemical tests (AST, ALT, ALP, total bilirubin, albumin, CRP, BUN, creatinine, eGFR, cystatin-C, blood glucose, HbA1c, TRACP-5b, P1NP, 25(OH)D, electrolytes, etc.)
Body Composition Analysis (body weight, BMI, skeletal muscle mass, skeletal muscle mass index, body fat mass, phase angle, etc.)
Blood and Saliva Biomarkers (inflammation-related markers, stress-related markers, nutrition- and metabolism-related proteins, bone metabolism-related factors, etc.)
Oral Microbiome
Management information
Registered date
| 2026 | Year | 06 | Month | 28 | Day |
Last modified on
| 2026 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071036
