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 2022/09/14 18:37:15

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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

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

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


Email

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

Email

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


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

40000

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

No longer recruiting

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

2022 Year 09 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055665


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name