UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041498 |
|---|---|
| Receipt number | R000047153 |
| Scientific Title | Real-world evaluation of epidemiology, treatment environment and bone fracture risk associated with glucocorticoid-induced osteoporosis in Japan |
| Date of disclosure of the study information | 2020/08/22 |
| Last modified on | 2022/06/15 09:28:17 |
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Basic information
Public title
Real-world evaluation of epidemiology, treatment environment and bone fracture risk associated with glucocorticoid-induced osteoporosis in Japan
Acronym
Real-world evaluation of epidemiology, treatment environment and bone fracture risk associated with glucocorticoid-induced osteoporosis in Japan
Scientific Title
Real-world evaluation of epidemiology, treatment environment and bone fracture risk associated with glucocorticoid-induced osteoporosis in Japan
Scientific Title:Acronym
Real-world evaluation of epidemiology, treatment environment and bone fracture risk associated with glucocorticoid-induced osteoporosis in Japan
Region
| Japan |
Condition
Condition
Glucocorticoid-induced osteoporosis (GIOP)
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the epidemiology, treatment patterns and adverse outcomes associated with GIOP using DPC claims database collected from acute care hospitals in Japan
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Longitudinal occurrence of GIOP-related fractures
Key secondary outcomes
Duration of oral GC,
Average oral GC dose per day,
Proportion of patients who received GIOP treatment,
Proportion of patients undergoing regular spinal X-ray,
Proportion of patients undergoing regular bone densitometry
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 newly prescribed oral GC between April 2009 and March 2019, having a total GIOP score of three or more, not considering a score by lumber bone density based on the JSBMR 2014 guideline
Key exclusion criteria
Having been diagnosed with any endocrine disease of interest which associated with reduced bone density
Target sample size
40000
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Kimura |
Organization
DAIICHI SANKYO CO., LTD.
Division name
Primary Medical Science Department, Medical Affairs Division, Japan Business Unit
Zip code
103-8426
Address
3-5-1 Nihonbashi Honcho Chuo-ku, Tokyo
TEL
03-6225-1053
kimura.tetsuya.d2@daiichisankyo.co.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Nomoto |
Organization
Creativ-Ceutical K.K.
Division name
HEOR
Zip code
108-6028
Address
Level 28 Sinagawa Intercity Tower A 2-15-1 Konan Minato-ku, Tokyo
TEL
03-6717-4160
Homepage URL
mariko.nomoto@creativ-ceutical.com
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
Japan
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
| 2020 | Year | 08 | Month | 22 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/content/pdf/10.1007/s00774-022-01325-7.pdf
Number of participants that the trial has enrolled
25569
Results
The fracture rate (all sites) at one year after steroid prescriptions was 9.3% [95% CI: 8.8-9.8] in steroid-exposed group and 5.8% [5.4-6.2] in steroid-unexposed group. The fracture rate was higher in steroid-exposed group compared to steroid-unexposed group.
Results date posted
| 2022 | Year | 06 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Average age: 66.8 years old, Female (54.5%)
Participant flow
The epidemiological survey was conducted on 13,342 patients who had not been diagnosed with cancer out of 25,569 patients with steroid-induced osteoporosis (GIOP) extracted from claims database of acute hospitals. Bone fracture risk was investigated on 13,342 patients who were not diagnosed with cancer and 13,090 one-to-one matched control population patients with similar characteristics who were not diagnosed with cancer.
Adverse events
Not applicable
Outcome measures
One-year vertebral fracture rates were 4.3 [4.0-4.7] and 2.3 [2.1-2.6] respectively. In the multivariate analysis, the use of glucocorticoid was associated with an increase in the incidence of osteoporotic fractures (hazard ratio: 1.63 [1.51-1.76]). The glucocorticoid-associated risk tended to be higher in subgroups of patients with rheumatoid arthritis, asthma, COPD and in those aged <65 years.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 03 | Month | 09 | Day |
Other
Other related information
Database study on glucocorticoid-induced osteoporosis in Japan.
This study is an observational study using anonymized data and IRB approval is not required.
Publication:
https://link.springer.com/content/pdf/10.1007/s00774-022-01325-7.pdf
https://link.springer.com/content/pdf/10.1007/s00774-021-01236-z.pdf
Management information
Registered date
| 2020 | Year | 08 | Month | 21 | Day |
Last modified on
| 2022 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047153
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