Clinical trial NCT00376740 (phase 3, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: zoledronic acid
SMILES: OC(CN1C=CN=C1)(P(O)(O)=O)P(O)(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women with histologically documented early (non-metastatic) breast
             cancer

          -  Previous treatment with tamoxifen for at least 2.5 years and not more than 3.5 years

          -  Assigned to receive letrozole treatment

          -  Karnofsky performance status ≥ 70

          -  Life expectancy ≥ 16 weeks

          -  Signed informed consent after full explanation of study by participating clinician and
             prio to any study specific procedures

          -  Adjuvant or neoadjuvant chemotherapy is allowed

          -  No clinical and/or radiologic evidence of distant metastases

          -  No prior treatment with an aromatase inhibitor

          -  Able to comply with treatment and scheduled follow-up visits

          -  Age between 18 and 82 years

        Exclusion Criteria:

          -  Pregnant or lactating women or women with child bearing potential

          -  Patients with other malignancies except except adequately treated basal cell carcinoma
             of the skin or in-situ cervix carcinoma

          -  Active infection or other serious underlying medical condition which would impair the
             ability of the patient to receive protocol treatment

          -  Clinical and/or radiological evidence of distant metastases.

          -  Evidence of pathological fracture

          -  Prior treatment with an aromatase inhibitor

          -  Prior administration of any intravenous bisphosphonate during the last year.

          -  Oral bisphosphonate must be discontinued within 4 weeks of enrollment

          -  Administration of long-term systemic corticosteroids within the last 12 months (short
             term steroid treatment is allowed.)

          -  Prior use of parathyroid hormone treatment for more than 1 week

          -  Use of any drug known to affect the skeleton (calcitonin, mithramycin, gallium
             nitrate) within two weeks prior to enrollment

          -  Abnormal renal function: creatinine clearance must be above 30 ml/min (calculated by
             Cockroft formula)

          -  Evidence of metabolic bone disease( Paget's, osteogenesis imperfecta,
             hyperparathyroidism within the 12 months prior to enrollment)

          -  Baseline lumbar spine and or total hip Bone Mineral Density T score below -2

          -  Known hypersensitivity to zoledronic acid

          -  Psychological, familial, sociologic, or geographic conditions which do not permit
             medical follow-up and compliance with the study protocol

          -  White blood cell ≤ 3.0 x 10exp9 /L or granulocytes ≤ 1.5 x 10exp9/L or platelets ≤100
             x 10exp9

          -  Total bilirubin> 1.5 x upper normal limit, SGOT and SGPT > 2.5 x upper normal limit

          -  Unable to undergo DXA bone density scanning (spine deformity, severe scoliosis, lumbar
             sacral spine surgery)