Single Dosing of Zoledronic Acid in Cancer Therapy Induced Bone Loss (CTIBL)

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Collaborator: Novartis
• Treatments: Diphosphonates; Zoledronic Acid

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).