UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054749 |
|---|---|
| Receipt number | R000062531 |
| Scientific Title | A Database Study Investigating the Impact of Osteoporosis Treatment Interventions on Fracture Risk in Japanese Dialysis Patients |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2026/06/16 15:22:18 |
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Basic information
Public title
A Database Study Investigating the Impact of Osteoporosis Treatment Interventions on Fracture Risk in Japanese Dialysis Patients
Acronym
A Database Study Investigating the Impact of Osteoporosis Treatment Interventions on Fracture Risk in Japanese Dialysis Patients
Scientific Title
A Database Study Investigating the Impact of Osteoporosis Treatment Interventions on Fracture Risk in Japanese Dialysis Patients
Scientific Title:Acronym
A Database Study Investigating the Impact of Osteoporosis Treatment Interventions on Fracture Risk in Japanese Dialysis Patients
Region
| Japan |
Condition
Condition
Chronic Kidney Disease stage 5D
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the impact of osteoporosis treatment interventions on fracture risk in maintenance dialysis patients using an insurer claims database.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence rate of Bone fractures
Key secondary outcomes
All-cause mortality
The implementation of bone density testing
The prescription of osteoporosis treatment drugs
Incidence rate of overt cardiovascular complications
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
1) Patients who received maintenance dialysis treatment for more than one year between April 1, 2012, and August 31, 2022
2) Age >=18 at baseline date
Key exclusion criteria
1) Patients who underwent kidney transplantation before the baseline date
2) Patients with a history of diseases related to decreased bone density or prescription history of osteoporosis drugs before the baseline date
3) Patients with a confirmed diagnosis of cancer beore the index date
Target sample size
100000
Research contact person
Name of lead principal investigator
| 1st name | Yoshi |
| Middle name | |
| Last name | Yasuda |
Organization
Daiichi Sankyo Co., Ltd.
Division name
Primary Medical Science Department
Zip code
103-0023
Address
3-5-1 Nihonbashi Honcho, Chuo-ku, Tokyo, Japan.
TEL
03-6225-1111
yasuda.yoshi.gn@daiichisankyo.co.jp
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Shintani |
Organization
Osaka Metropolitan University
Division name
Department of Medical Statistics
Zip code
545-8585
Address
1-3-4 Asahimachi, Abeno-ku, Osaka, Japan.
TEL
06-6645-3894
Homepage URL
med-statacademy@ml.omu.ac.jp
Sponsor or person
Institute
Daiichi Sankyo Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NA
Address
NA
Tel
NA
NA
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
| 2024 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10157-026-02858-1
Number of participants that the trial has enrolled
156557
Results
A total of 38,246 maintenance dialysis patients were analyzed (treated: 1,093; untreated: 37,153).
No significant difference was observed in total fracture risk (SHR 1.137, 95% CI 0.996-1.299, P=0.058).
No significant difference was observed in hip fracture risk (SHR 0.945, 95% CI 0.722-1.236, P=0.680).
No significant differences were observed in all-cause mortality (HR 1.327, 95% CI 0.985-1.788, P=0.063) or cardiovascular disease incidence (SHR 1.006, 95% CI 0.912-1.109, P=0.910).
Results date posted
| 2026 | Year | 06 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 04 | Month | 25 | Day |
Baseline Characteristics
This study used the DeSC-IQVIA Integrated Claims Data and included maintenance dialysis patients between April 1, 2014 and August 31, 2022. A total of 38,246 eligible patients were analyzed, including 1,093 patients in the osteoporosis treatment group and 37,153 patients in the untreated group. Overall, 66.8% were male and 71.5% were aged 65 years or older. A history of fracture was present in 46.8% of patients in the treatment group and 15.8% in the untreated group. The most common comorbidities were hypertension (96.5%), diabetes mellitus (60.0%), and dyslipidemia (54.1%).
Participant flow
Participant Selection: Data from the DeSC-IQVIA Integrated Claims Data between April 1, 2014 and August 31, 2022 were used to identify 156,557 patients who had received maintenance dialysis for at least 2 years. Eligibility assessment was performed according to the predefined inclusion and exclusion criteria.
Exclusion Criteria:
History of conditions associated with decreased bone mineral density or osteoporosis medication use before baseline.
Kidney transplantation, malignancy, or parathyroidectomy before the index date.
Death before the index date.
Final Analysis Set:
Osteoporosis treatment group: 1,093 patients. Untreated group: 37,153 patients. Total: 38,246 patients.
Adverse events
This study is a retrospective database study using DPC data, and there were no interventions or direct involvement with the participants. Therefore, no adverse events could occur.
Outcome measures
The primary outcome was the incidence of fractures (total fractures and hip fractures) after the index date.
Secondary outcomes included bone mineral density measurement rates, prescription rates of osteoporosis and bone metabolism-related medications, all-cause mortality, and the incidence of cardiovascular disease (atrial fibrillation, congestive heart failure, stroke, angina pectoris, and myocardial infarction).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a database study using the insurance claims database (IQVIA Claims Plus 2). The patient cohort with prescriptions for osteoporosis treatments within one year from the baseline date is defined as the osteoporosis treatment group, while the cohort without such prescriptions is defined as the untreated osteoporosis group.
Management information
Registered date
| 2024 | Year | 06 | Month | 24 | Day |
Last modified on
| 2026 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062531
