UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054784 |
|---|---|
| Receipt number | R000062598 |
| Scientific Title | Effectiveness of osteoporosis medications to prevent secondary fractures in the elderly with a history of osteoporotic fractures: a historical cohort study |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2025/09/29 16:31:16 |
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Basic information
Public title
Effectiveness of osteoporosis medications to prevent secondary fractures in the elderly with a history of osteoporotic fractures: a historical cohort study
Acronym
Effectiveness of osteoporosis medications to prevent secondary fractures in the elderly with a history of osteoporotic fractures: a historical cohort study
Scientific Title
Effectiveness of osteoporosis medications to prevent secondary fractures in the elderly with a history of osteoporotic fractures: a historical cohort study
Scientific Title:Acronym
Effectiveness of osteoporosis medications to prevent secondary fractures in the elderly with a history of osteoporotic fractures: a historical cohort study
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Geriatrics | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of osteoporosis drugs in preventing secondary fractures in elderly people aged 75 years or older with a history of osteoporotic fractures.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of secondary fracture
Key secondary outcomes
Secondary fracture details(Hip,Vertebral,Radius,Humerus,Other)
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 aged 75 years or older with a fracture
2.Patients who have information in the database for 365 days before the fracture date (index date)
3.Patients who had any related surgery, procedure,or hospitalization in the same month or the month after the baseline fracture occurred.
Key exclusion criteria
1.Patients who received osteoporosis drugs for 365 days before the fracture date (index date)
2.Patients with a disease name of fracture 365 days to 61 days before the date of fracture (index date)(excluding suspected cases)
3.People without health insurance
Target sample size
155147
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
-
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
Japanese Bone-fracture Osteoporosis in Late-stage elderly Database 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 | 07 | Month | 01 | Day |
Related information
URL releasing protocol
none
Publication of results
Published
Result
URL related to results and publications
Osteoporosis International
Number of participants that the trial has enrolled
203534
Results
Analysis of a database of elderly people revealed that administering osteoporosis medication to patients aged 75 or older with osteoporotic fractures reduced secondary fractures.
Results date posted
| 2024 | Year | 08 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 09 | Month | 04 | Day |
Baseline Characteristics
In the study period, 203,534 individuals met the eligibility criteria; 40,063 were exposed and 163,471 were considered controls. After hdPSM, 53,436 (26,718 exposed, 26,718 controls) were analyzed.The mean age was 83.7 years, and 77.9% were women.
Participant flow
Patients were enrolled if they were 75 years of age or older, had a femur fracture, vertebral fracture, radius fracture, humerus fracture, or other fracture site, and had data in the database for the 365 days prior to the fracture.
Adverse events
Since this is a database study, no safety issues have been raised.
Outcome measures
The primary outcome was a composite measure of the secondary fracture sites, identified as fractures with a different disease code in the ICD-10 category from that of the index fracture.
Secondary outcomes included individual site-specific fracture incidences and their respective hazard ratios (HRs).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2023 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 06 | Month | 15 | Day |
Date analysis concluded
| 2024 | Year | 06 | Month | 30 | Day |
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 06 | Month | 26 | Day |
Last modified on
| 2025 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062598
