Single Dosing of Zoledronic Acid in Cancer Therapy Induced Bone Loss (CTIBL)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Zometa
Intervention description: Zometa (Zoledronic Acid) 5 mg IV over 15 minutes in a one time dose
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Breast cancer; aromatase inhibitors

Summary:

      The purpose of this research is to establish if a once a year dose of Zoledronic Acid is
      sufficient to suppress and maintain urine and serum bone density markers (NTx) and serum CTx
      within normal range at 12 months post-dosing in postmenopausal early breast cancer patients
      receiving additional treatment with non-steroidal aromatase inhibitors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women with Stage I, II or IIIa breast cancer being treated with a
             non-steroidal Aromatase Inhibitor (AI) .Negative bone scan (no bone metastases).

          -  Calculated creatinine clearance > 40 ml/min

          -  Documented T score of less than or equal to -1.5 on Dual Energy X-ray Absorptiionmetry
             (DXA) scan at the lumbar spine or femoral neck within 3 months prior to screening.

          -  Urine NTx > 50 nano moles(nM)based on second morning void.

          -  Signed informed consent.

          -  Ambulatory patients at least 18 years of age.

          -  Eastern Cooperative Oncology Group (ECOG)0-2.

          -  Ability to comply with trial requirements.

        Exclusion Criteria:

          -  Bone Metastases.

          -  Any woman of child bearing potential.

          -  Patients with fractures occurring within three months prior to randomization. -
             Greater than a 2+ protein on urine dipstick without evidence of contamination or
             bacteriuria (may be repeated one time, at least a day apart).

          -  Calculated creatinine clearance less than 30 mL/min at screening.

          -  Serum calcium > 2.75 mmol/L (11.0 mg/dL) or < 2.00 mmol/L (8.0 mg/dL).

          -  Liver Function tests (LFT)> 2.0 x upper limit of normal (ULN).

          -  Serum alkaline phosphatase > 1.5 x ULN. History of hypersensitivity to
             bisphosphonates.

          -  Evidence of vitamin D deficiency (serum 25-(OH) D of less than 15 ng/ml).

          -  History of uveitis or iritis, except when secondary to trauma, and must have resolved
             > 2 years prior to entry.

          -  A history of invasive malignancy of any organ system, treated or untreated, within the
             past 12 months prior to screening; excluding, basal cell or squamous cell carcinoma of
             the skin, colonic polyps with non-invasive malignancy which have been removed, Ductal
             Carcinoma in-situ (DCIS) that has been surgically removed, and Carcinoma in-situ (CIS)
             of the uterine cervix that has been surgically removed.

          -  Previous major solid organ transplant recipient or on a transplant waiting list.

          -  Treatment with any investigational drug within 30 days prior to randomization.

          -  History of hyperparathyroidism, hypoparathyroidism, Osteogenesis imperfecta, Paget's
             disease or any metabolic bone disease other than osteoporosis.

          -  Any medical condition which would interfere with the action of the study drug or limit
             life expectancy to less than 6 months.

          -  Any medical or psychiatric condition which, in the opinion of the investigator, would
             preclude the participant from adhering to the protocol or completing the trial.

          -  Prior treatment with IV bisphosphonates within the last 2 years.

          -  Previous use of oral bisphosphonates within the past 2 years (unless used for less
             than 8 weeks*). *NOTE: If used less than 8 weeks, the washout period is 6 months.

          -  Treatment with raloxifene, calcitonin, tibolone or hormone replacement therapy. The
             washout period for these medications is 6 months prior to randomization.

          -  Any treatment with strontium ranelate, samarium, sodium fluoride or parathyroid
             hormone.

          -  Use of systemic high dose corticosteroids at an average dose of > 7.5 mg per day of
             oral prednisone or equivalent for a period of three months or more prior to screening.

          -  Known hypersensitivity to zoledronic acid or other bisphosphonates.

          -  Current active dental problems including infection of the teeth or jawbone (maxilla or
             mandibular); dental or fixture trauma, or a current or prior diagnosis of
             osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after
             dental procedures.

          -  Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants).