UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056232 |
|---|---|
| Receipt number | R000063769 |
| Scientific Title | A retrospective cohort study of older adults with osteoporotic fractures: Sub analysis 2 (vertebral fractures and upper limb fractures) |
| Date of disclosure of the study information | 2024/12/02 |
| Last modified on | 2026/02/26 14:37:09 |
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Basic information
Public title
A retrospective cohort study of older adults with osteoporotic fractures: Sub analysis 2 (vertebral fractures and upper limb fractures)
Acronym
A retrospective cohort study of older adults with osteoporotic fractures: Sub analysis 2 (vertebral fractures and upper limb fractures)
Scientific Title
A retrospective cohort study of older adults with osteoporotic fractures: Sub analysis 2 (vertebral fractures and upper limb fractures)
Scientific Title:Acronym
A retrospective cohort study of older adults with osteoporotic fractures: Sub analysis 2 (vertebral fractures and upper limb fractures)
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Geriatrics | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the background and treatment status of elderly patients with osteoporotic fractures.
To clarify the interventions status and outcomes after osteoporotic vertebral fractures and or/or upper limb fractures .
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The occurrence of secondary fractures or surgery in patients with vertebral fractures and/or upper limb fractures.
Key secondary outcomes
Mortality and other clinical outcomes in patients with vertebral and/or upper limb fractures.
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
| 75 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with osteoporotic fractures
2.Subjects in the database between April 1, 2014 and March 31, 2025
3.Subjects aged 75 years or older
Key exclusion criteria
1.No data available after insurance enrollment.
2.Set for each analysis
Target sample size
1000000
Research contact person
Name of lead principal investigator
| 1st name | Takahiko |
| Middle name | |
| Last name | Hamasaki |
Organization
Japan Organization of Occupational Health and safety
Chugoku Rosai Hospital
Division name
Orthopedics
Zip code
737-0134
Address
1-5-1 Hirotagaya Kure-City Hiroshima Pre.
TEL
0823-72-7171
taka_ham@d3.dion.ne.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Saito |
Organization
Datack, Inc.
Division name
none
Zip code
102-0072
Address
707, 1-8-9, Iidabashi Chiyoda-ku, Tokyo
TEL
080-1712-5964
Homepage URL
info@datack.jp
Sponsor or person
Institute
J-BOLD Study Group
Institute
Department
Personal name
Funding Source
Organization
Asahi Kasei Pharma Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asai Dermatology Institutional Review Board
Address
1-14 Tomoko-cho, Hodogaya-ku, Yokohama-shi, Kanagawa
Tel
03-5543-0196
jimukyoku@smo-msr.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
| 2024 | Year | 12 | Month | 02 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
Results are not yet available due to an extended period of subjects in the database.
Number of participants that the trial has enrolled
1000000
Results
Results are not yet available as the period of subjects in the database has been extended.
Results date posted
| 2026 | Year | 02 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The participant background is not yet available as the period of subjects in the database has been extended.
Participant flow
The flow of participants is still ongoing due to the extended period of subjects present in the database.
Adverse events
Adverse event results are still pending due to the extended duration of subjects present in the database.
Outcome measures
The study results have not yet been registered due to the extended period of subjects in the database.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 10 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 11 | Month | 22 | Day |
Last modified on
| 2026 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063769
