Cancer Treatment-Induced Bone Loss (CTIBL)
Conditions
Interventions
None listed
Sponsors
DAIICHI SANKYO CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All fractures and site-specific fracture risk analysis: - Time-to-event analysis - Evaluations of fracture risk (univariate/multivariate analysis) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactMariko Nomoto
Creativ-Ceutical K.K. PRMA
Outcome results
None listed