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

Novartis Pharmaceuticals527 enrolled

Overview

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 IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

527

Conditions

Breast Cancer

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Stage I-IIIa breast cancer * Postmenopausal * Recent surgery for breast cancer Exclusion Criteria: * Metastatic disease * Invasive bilateral disease * Clinical or radiological evidence of existing fracture in spine or hip Other protocol-defined inclusion / exclusion criteria may apply.

Locations (49)

Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site

Rosario - Santa Fe, Argentina

Novartis Investigative Site

Aalst, Belgium

Novartis Investigative Site

Anderlecht, Belgium

Novartis Investigative Site

Bonheiden, Belgium

Novartis Investigative Site

Outcomes

Primary Outcomes

Percent Change in Lumbar Spine (L2-L4) BMD After 12 Months of Letrozole Therapy

Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = \[(BMD at Visit - BMD at Baseline) / BMD at Baseline\] \* 100.

Time frame: From Baseline - 12 months

Secondary Outcomes

Percent Change in Lumbar Spine (L2-L4) BMD at 2 Years, 3 Years, 4 Years and 5 Years

Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = \[(BMD at Visit - BMD at Baseline) / BMD at Baseline\] \* 100.

Time frame: From Baseline to Year 2, Year 3, Year 4, Year 5

Percent Change in Lumbar Spine (L1-L4) BMD at Year 1, Year 2, Year 3, Year 4 and Year 5

Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = \[(BMD at Visit - BMD at Baseline) / BMD at Baseline\] \* 100.

Time frame: From Baseline to Year 1, Year 2, Year 3, Year 4, Year 5

Percent Change in Total Hip BMD at Year 1, Year 2, Year 3, Year 4 and Year 5

Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = \[(BMD at Visit - BMD at Baseline) / BMD at Baseline\] \* 100.

Time frame: From baseline to Year 1, Year 2, Year 3, Year 4, Year 5

Percentage of Participants With Radiological (Vertebra) Fractures Which Were Not Present at Baseline But Were Present at Year 3

Radiological Fracture at 36 months which was not present at baseline = (new fracture/number participant analyzed)\*100. Evaluation of radiological fractures were based on central lab X-ray data. A subject with multiple fractures at the same time or multiple fractures with the same grade is counted only once for that treatment.

Time frame: Year 3