None listed
Conditions
Interventions
Zolendronic acid Type of group
Zolendronic acid 4 mg Intravenous (IV) infusion of 15 minutes every 6 months for 5 years from day 1. All participants took letrozole tablets 2.5 mg / day for 5 years from day 1.
Sponsors
NOVARTIS PHARMACEUTICALS CORPORATION,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent. 2. O - 2 performance level according to the Cooperative Oncology Group Eastem. 3. Postmenopausal state 4. Premenopausal women (ie, recent postmenopausal women) who are / become amenorrheic due to chemotherapy, use of LHRH, or surgical ablation of the ovaries. 5. Positivity for hormone receptors defined as RE and / or RP> 10 finol / mg of cytosolic protein; or> 10% of positive tumor cells by immunohistochemical evaluation. 6. Patients with a T score for DM0 of the lumbar spine and total hip of or greater than - 2.0 SD.
Exclusion criteria
Exclusion criteria: 1. Patients with some clinical or radiological evidence of distant dissemination of their disease at some time before randomization. 2. Patients with bilateral breast cancer. 3. Patients with some clinical or radiological evidence of fracture existing in the lumbar spine and / or total hip. 4. Patients with a history of low density fracture or not associated with trauma. 5. Patients who have started adjuvant hormone therapy or who have completed adjuvant hormone therapy before randomization. 6. Patients who have received any endocrine therapy during the last 12 months (apart from tamoxifen or torimefeno neoadjuvants, insulin and / or hypoglycaemic medications, and thyroid hormone replacement). Hormone replacement therapy should be discontinued at least 4 weeks before randomization. 7. Patients who have received previous treatment with intravenous bisphosphonates during the last 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Percentage change from the baseline measurement in the BMD of the lumbar spine (£ 4 L2 to L4). The primary time point for the analysis will be 12 months (12 months after the end of the recruitment). Measure:Percentage change in BMD of the lumbar spine (L1 aL 4), determined by dual X-ray absorptiometry (DEXA), at 12 months in recent postmenopausal and postmenopausal women with breast cancer positive for hormonal receptors randomized to Zometa® from the start versus delayed start. Timepoints:every 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:1) the percentage change in BMD in the lumbar spine at 2, 3, 4 and 5 years between the two treatment groups. 2) the percentage change in BMD in the lumbar spine DMO at 12 months, 2, 3, 4 and 5 years between the two treatment groups. 3) the percentage change in BMD in the total hip at 2, 3, 4 and 5 years between the two treatment groups. 4) the rate of decrease in BMD in the lumbar spine between the two treatment groups during the course of the study. Measure:1. the percentage change in DM0 in the lumbar spine (L1 to L4) at 2, 3 and 5 years between the two treatment groups. 2. the percentage change in DM0 in the total hip at 2, 3 and 5 years between the two treatment groups. 3. the rate of decrease of DM0 in the lumbar spine (L1 to L4 between the two treatment groups during the course of the study. 4. the rate of decrease in DM0 in the total hip between the two treatment groups during the course of the study. Timepoints:every 6 weeks | — |
Countries
Peru, United States
Outcome results
None listed