Study on the epidemiology of cancer treatment-related osteopenia, clinical practice, and fracture risk using the Japanese medical information database
- Conditions
- Cancer Treatment-Induced Bone Loss (CTIBL)
- Registration Number
- JPRN-UMIN000048942
- Lead Sponsor
- DAIICHI SANKYO CO., LTD.
- Brief Summary
Major results are shown in the publication
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 47860
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All fractures and site-specific fracture risk analysis: - Time-to-event analysis - Evaluations of fracture risk (univariate/multivariate analysis)
- Secondary Outcome Measures
Name Time Method 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