Status:
COMPLETED
Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Bone Loss
Breast Cancer
Eligibility:
FEMALE
Phase:
PHASE3
Brief Summary
Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg...
Eligibility Criteria
Inclusion
- Stage I-IIIa breast cancer
- Postmenopausal or recently postmenopausal
- Recent surgery for breast cancer
- Estrogen Receptor positive and/or progesterone receptor positive hormone receptor status
- No prior treatment with letrozole
- Other protocol-defined inclusion criteria may apply.
Exclusion
- Metastatic disease
- Invasive bilateral disease
- Clinical or radiological evidence of existing fracture in spine or hip
- Prior treatment with IV bisphosphonates in the past 12 months
- Current treatment with oral bisphosphonates ( must be discontinued within 3 weeks of baseline evaluation)
- Use of Tibolone within 6 months
- Prior use of parathyroid hormone for more than 1 week
- Previous or concomitant malignancy
- Abnormal renal function
- History of disease effecting bone metabolism
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
1065 Patients enrolled
Trial Details
Trial ID
NCT00171340
Start Date
May 1 2003
End Date
February 1 2010
Last Update
April 16 2012
Active Locations (106)
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1
Novartis Investigative Site
Buenos Aires, Argentina
2
Novartis Investigative Site
Rosario Santa Fe, Argentina
3
Novartis Investigative Site
New South Wales, Australia
4
Novartis Investigative Site
Perth, Australia