Status:
COMPLETED
Single Dosing of Zoledronic Acid in Cancer Therapy Induced Bone Loss (CTIBL)
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
Novartis
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 rang...
Detailed Description
Bone metastases are frequently one of the first signs of disseminated disease in cancer patients. Skeletal complications due to metastatic disease include (severe) bone pain, spinal cord compromise, p...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00712985
Start Date
September 1 2005
End Date
March 1 2011
Last Update
April 24 2014
Active Locations (1)
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1
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033