A Study to Evaluate the Effect of Letrozole and Tamoxifen on Bone and Lipids in Postmenopausal Women With Breast Cancer

Exclusion Criteria

• •Patients with distant metastases as defined by the criteria of the Danish Breast Cancer Co-operative Group (DBCCOG).
• •Pre-existing bone disease (e.g. osteomalacia, osteogenesis imperfecta, Paget's disease).
• •Patients receiving bisphosphonates for more than 3 months before randomization.
• •Chronic treatment with drugs known to interfere with bone metabolism, e.g.
• •Anti-convulsants within the past year.
• •Corticosteroids at doses greater than the equivalent of 5 mg/day prednisone for more than two weeks in the past 6 months (prior to randomization).
• •Any previous treatment with sodium fluoride at daily doses ≥ 5 mg/day for a period exceeding 1 month.
• •Anabolic steroids in the past 12 months.
• •Long term use of coumarin derivatives and heparin at the time of randomization.
• •Metabolic diseases known to interfere with bone metabolism (e.g., Hyperparathyroidism, hypoparathyroidism, uncontrolled thyroid disease, Cushing's disease, vitamin D deficiency, malabsorption syndrome, etc.).
• •Treatment with lipid-lowering agents within the 3 months prior to randomization (this exclusion criterion did not apply to patients randomized in the United Kingdom).
• •Patients receiving other anti-cancer treatment.
• •Previous neoadjuvant / adjuvant chemotherapy and /or previous adjuvant endocrine therapy (e.g., anti-estrogens, AIs).
• •History of previous or concomitant malignancy within the past 5 years other than adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who had a previous other malignancy must have been disease free for five years. Patients with endometrial cancer and/or invasive breast cancer at any time in their medical history were excluded. Patients with invasive bilateral breast cancer were excluded. Patients with vaginal discharge/ vaginal bleeding with evidence of malignancy were excluded.
• •Any other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, etc.) which would prevent prolonged follow-up.