UMIN-CTR Clinical Trial

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
Email	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
Email	mariko.nomoto@creativ-ceutical.com

Sponsor
Institute	DAIICHI SANKYO CO., LTD.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047153