UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048942 |
|---|---|
| Receipt number | R000055665 |
| Scientific Title | Study on the epidemiology of cancer treatment-related osteopenia, clinical practice, and fracture risk using the Japanese medical information database |
| Date of disclosure of the study information | 2022/09/23 |
| Last modified on | 2024/04/22 16:17:10 |
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Basic information
Public title
Study on the epidemiology of cancer treatment-related osteopenia, clinical practice, and fracture risk using the Japanese medical information database
Acronym
Study on the epidemiology of cancer treatment-related osteopenia, clinical practice, and fracture risk using the Japanese medical information database
Scientific Title
Study on the epidemiology of cancer treatment-related osteopenia, clinical practice, and fracture risk using the Japanese medical information database
Scientific Title:Acronym
Study on the epidemiology of cancer treatment-related osteopenia, clinical practice, and fracture risk using the Japanese medical information database
Region
| Japan |
Condition
Condition
Cancer Treatment-Induced Bone Loss (CTIBL)
Classification by specialty
| Endocrinology and Metabolism | Breast surgery | Obstetrics and Gynecology |
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to estimate fracture risk in patients with breast or prostate cancer treated with hormonotherapy in Japan.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
All fractures and site-specific fracture risk analysis:
- Time-to-event analysis
- Evaluations of fracture risk (univariate/multivariate analysis)
Key secondary outcomes
Patient characteristics at index date:
- Age, Sex, Facility category and department
- Hormone therapies: Types of hormone therapy medications and cumulative number of days of hormone therapy administered
- Comorbidities at index month, and during pre-index period
- Bone mineral density test before and after the index date
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
<Hormone therapy cohort>
Patients who meet either of the following criteria are included:
1) Patients with a confirmed diagnosis of breast or prostate cancer during the study period
2) Patients who have received hormone therapy for breast or prostate cancer during the selection period
3) Patients aged 18 years or older at the baseline date
4) Patients who have a certain period of time during the pre-baseline period
5) Patients who have a certain period of time during the post-baseline period
<Non-hormone therapy cohort>
Patients who meet either of the following criteria are included:
1) Patients with a confirmed diagnosis of breast or prostate cancer during the study period
2) Patients who have not received hormone therapy for breast or prostate cancer during the selection period
3) Patients aged 18 years or older at the baseline date
4) Patients who have a certain period of time during the pre-baseline period
5) Patients who have a certain period of time during the post-baseline period
<Non-cancer cohort>
Patients who meet either of the following criteria are included:
1) Patients without a confirmed diagnosis of cancer
2) Patients aged 18 years or older at the baseline date
3) Patients who have a certain period of time during the pre-baseline period
4) Patients who have a certain period of time during the post-baseline period
Key exclusion criteria
Patients who meet either of the following criteria are excluded:
1) Male patients with a confirmed diagnosis of breast cancer and female patients with a confirmed diagnosis of prostate cancer during the study period
2) Patients diagnosed with a disease related to reduced bone mineral density during the study period
3) Patients with a confirmed diagnosis of osteoporosis or fracture before the baseline date
4) Patients with at least 2 confirmed diagnosis of osteoporosis and at least one prescription of osteoporosis drug during the pre-baseline period
For breast cancer patients, those who meet the following condition are also excluded:
1) Patients with a previous confirmed diagnosis of cancer (recurrent or metastatic cancer) prior to receiving a confirmed diagnosis of cancer for this study
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
Zip code
103-8426
Address
3-5-1 Nihonbashi Honcho Chuo-ku, Tokyo, Japan
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
PRMA
Zip code
108-6028
Address
Level 28 Shinagawa Intercity Tower A, 2-15-1 Konan Minato-ku, Tokyo, Japan
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
Research Institute of Healthcare Data Science
Address
Level 12 Shibadaimon building 2-5-5 Shibadaimon Minato-ku, Tokyo, Japan
Tel
03-5733-5010
rihds@jmdc.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
| 2022 | Year | 09 | Month | 23 | Day |
Related information
URL releasing protocol
Not available (N/A)
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/38493435/ , https://pubmed.ncbi.nlm.nih.gov/38588537/
Number of participants that the trial has enrolled
47860
Results
Major results are shown in the publication
Results date posted
| 2024 | Year | 04 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Please refer to the publication
Participant flow
Please refer to the publication
Adverse events
Since this is database study using secondary database, there is no adverse event reported
Outcome measures
Please refer to the publicaiton
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study on the epidemiology of cancer treatment-related osteopenia, clinical practice, and fracture risk using the Japanese medical information database (retrospective cohort database study)
Management information
Registered date
| 2022 | Year | 09 | Month | 15 | Day |
Last modified on
| 2024 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055665
