jRCT1061210010Active, not recruitingNot Applicable
Efficacy and safety of zoledronic acid for postmenopausal women with early breast cancer receiving adjuvant aromatase inhibitor. (SBP-15)
Not provided0 sites200 target enrollmentStarted: July 7, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 200
- Primary Endpoint
- -
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Single Arm Study
- Intervention Model
- Single Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Open(masking Not Used)
Eligibility Criteria
- Ages
- No limit to No limit (—)
- Sex
- All
Inclusion Criteria
- •ER positive postmenopausal breast cancer patients
- •Patients recieving AI (<2 yerars)
- •Patients diagnosed osteoporosis
- •Patients without treatment of osteoporosis
- •CCr>35mL/min
- •Serum Ca>8.0 mg/dL
- •Without dental treatment
- •With informed consent
Exclusion Criteria
- •Metastatic breast cancer patients
- •Allargy with bisphosphonate
- •Renal disfunction
- •Active other cancers
- •Treated with bisphosphonate
- •The medical doctor judged ineligible
Outcomes
Primary Outcomes
-
3 years rate of bone density change
Secondary Outcomes
No secondary outcomes reported
Investigators
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