Status:

COMPLETED

The Use of Zoledronic Acid to Prevent Cancer-treatment Bone Loss in Post-menopausal Women Receiving Adjuvant Letrozole for Breast Cancer

Lead Sponsor:

Novartis Pharmaceuticals

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

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
  • Recent surgery for breast cancer

Exclusion

  • Metastatic disease
  • Invasive bilateral disease
  • Clinical or radiological evidence of existing fracture in spine or hip
  • Other protocol-defined inclusion / exclusion criteria may apply.

Key Trial Info

Start Date :

March 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

527 Patients enrolled

Trial Details

Trial ID

NCT00171314

Start Date

March 1 2004

Last Update

April 11 2012

Active Locations (49)

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Page 1 of 13 (49 locations)

1

Novartis Investigative Site

Buenos Aires, Argentina

2

Novartis Investigative Site

Rosario - Santa Fe, Argentina

3

Novartis Investigative Site

Aalst, Belgium

4

Novartis Investigative Site

Anderlecht, Belgium