UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054550 |
|---|---|
| Receipt number | R000062329 |
| Scientific Title | Perioperative treatment status and postoperative outcomes in osteoporotic patients with vertebral fractures: a retrospective longitudinal study of administrative claims data |
| Date of disclosure of the study information | 2024/06/03 |
| Last modified on | 2026/01/19 09:21:03 |
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Basic information
Public title
Perioperative treatment status and postoperative outcomes in osteoporotic patients with vertebral fractures: a retrospective longitudinal study of administrative claims data
Acronym
Perioperative treatment status and postoperative outcomes in osteoporotic patients with vertebral fractures
Scientific Title
Perioperative treatment status and postoperative outcomes in osteoporotic patients with vertebral fractures: a retrospective longitudinal study of administrative claims data
Scientific Title:Acronym
Perioperative treatment status and postoperative outcomes in osteoporotic patients with vertebral fractures
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Endocrinology and Metabolism | Surgery in general | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In osteoporosis patients with vertebral fractures who have undergone spinal surgery, analysis is performed by surgery type (spinal fusion or percutaneous vertebroplasty) to meet the following study objectives:
1) To investigate patient characteristics and treatment status during the perioperative period
2) To investigate the proportion of reoperation and the incidence of secondary vertebral fractures and/or hip fractures
3) To explore factors associated with the occurrence of reoperation and secondary fractures.
Basic objectives2
Others
Basic objectives -Others
Real-world clinical practice
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Patient characteristics (patient demographics and perioperative treatment status)
2. Occurrence of postoperative outcomes (reoperation, secondary vertebral fracture, hip fracture)
3. Factors associated with postoperative outcomes
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Underwent spinal surgery (spinal fusion or percutaneous vertebroplasty) between April 2015 and February 2021
2. Continuously registered in the DeSC database for one month after their first spinal surgery
3. Continuously registered in the DeSC database for the 12 months prior to the month of their first spinal surgery
4. Diagnosed with a vertebral fracture within 12 months prior to their first spinal surgery
5. Diagnosed with osteoporosis during the baseline period
6. 40 years of age or older
Key exclusion criteria
1. Spinal surgery (spinal fusion or percutaneous vertebroplasty) within the 12 months prior to the first spinal surgery of interest to this study
2. Infectious spondylitis during the baseline period
3. Metastatic or primary spinal tumors during the baseline period
4. Multiple myeloma during the baseline period
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Sugiyama |
Organization
Teijin Pharma Limited
Division name
Medical Science Department
Zip code
100-8585
Address
2-1, Kasumigaseki 3-chome, Chiyoda-ku, Tokyo
TEL
03-3506-4140
tpm-com@umin.ac.jp
Public contact
Name of contact person
| 1st name | Ruriko |
| Middle name | |
| Last name | Koto |
Organization
Teijin Pharma Limited
Division name
Medical Science Department
Zip code
100-8585
Address
2-1, Kasumigaseki 3-chome, Chiyoda-ku, Tokyo
TEL
03-3506-4140
Homepage URL
tpm-com@umin.ac.jp
Sponsor or person
Institute
Teijin Pharma Limited
Institute
Department
Personal name
Funding Source
Organization
Teijin Pharma Limited
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
Teijin Pharma Limited
Address
2-1, Kasumigaseki 3-chome, Chiyoda-ku, Tokyo
Tel
03-3506-4140
tpm-com@umin.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
| 2024 | Year | 06 | Month | 03 | 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
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a longitudinal study using the DeSC Database.
Management information
Registered date
| 2024 | Year | 06 | Month | 03 | Day |
Last modified on
| 2026 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062329
