Cancer
Conditions
Interventions
Zoledronic acid
placebo
Sponsors
AUH
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1- Histologic evidence of ER/PR positive breast adenocarcinoma 2- Postmenopausal women. 3- Baseline LS and total hip BMD T-score > -2.0. 4- No prior treatment with denosumab or IV bisphosphonates is allowed. 5- No prior treatment with radiopharmaceuticals. 6- Not pregnant and not nursing. 7- Good dental health. 8- ECOG performance status 0-2. 9- Calculated creatinine clearance >= 30 mL/min. 10- Corrected serum calcium >= 8.0 mg/dL (2.00 mmol/L) and < 11.6 mg/dL (2.90 mmol/L)
Exclusion criteria
Exclusion criteria: 1- Patients with dental problems. 2- Patients with impaired renal functions 3- Patients with osteopenia, or T- score is below -2.0 4- Patients with history of serious drug hypersensitivity or drug allergy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the percentage change in lumber spine (L2-L4) BMD at 12 months for immediate- versus delayed-ZOL patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end points will include percentage change in total hip BMD at each assessment, fracture incidence, time to disease recurrence (local relapse or distant metastasis), DFS, and safety. | — |
Countries
Egypt
Contacts
Public ContactRehab Farouk
prof. of clinical oncology at Assuit University Hospital
Outcome results
None listed