An Open-Label, Randomized, MultiCenter Study to Evaluate the Use of Zolendronic Acid in the Prevention of Cancer Treatment-Related Bone Loss in Postmenopausal Women With Estrogen Positive and/or Progesterone Positive Breast Cancer Receiving Letrozole as Adjuvant Therapy
N/A
N/A
Female
Bone Loss, Breast Cancer
Trial Information
An Open-Label, Randomized, MultiCenter Study to Evaluate the Use of Zolendronic Acid in the Prevention of Cancer Treatment-Related Bone Loss in Postmenopausal Women With Estrogen Positive and/or Progesterone Positive Breast Cancer Receiving Letrozole as Adjuvant Therapy
Inclusion Criteria:
- 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 Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy.
Outcome Description:
Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by energy x-ray absorptiometry (DXA).
Outcome Time Frame:
Baseline, 12 months
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
CFEM345D2405
NCT ID:
NCT00171340
Start Date:
May 2003
Completion Date:
February 2010
Related Keywords:
- Bone Loss
- Breast Cancer
- Bone Loss
- Osteopenia
- Breast cancer
- letrozole
- zoledronic acid
- postmenopausal
- Breast Neoplasms
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