MULTICENTER, OPEN, RANDOMIZED STUDY TO EVALUATE THE USE OF ZOLEDRONIC ACID IN THE PREVENTION OF BONE LOSS RELATED TO ONCOLOGICAL TREATMENT IN POSTMENOPAUSIC WOMEN WITH POSITIVE BREAST CANCER FOR RE AND / OR RP WHO RECEIVE LETROZOL AS AN ADJUVANT TREATMENT.
- Conditions
- -M810M810
- Registration Number
- PER-053-03
- Lead Sponsor
- OVARTIS PHARMACEUTICALS CORPORATION,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method