Status:
COMPLETED
Effectiveness of Zoledronic Acid in the Prevention of Osteoporosis in Early Breast Cancer Patients Receiving Letrozole
Lead Sponsor:
Soroka University Medical Center
Collaborating Sponsors:
Tel-Aviv Sourasky Medical Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-82 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether zoledronic acid given intravenously every 6 months can prevent reduction in bone mineral density in women with early stage breast cancer receiving adj...
Detailed Description
Letrozole is an aromatase inhibitor used in the treatment of hormone receptor positive metastatic breast cancer in postmenopausal women.It has more recently been approved for use in many countries as ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00376740
Start Date
September 1 2005
Last Update
August 23 2011
Active Locations (2)
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1
Soroka University Medical Center
Beersheba, Israel
2
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel