Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.

Novartis Pharmaceuticals1,065 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

1,065

Conditions

Bone Loss Breast Cancer

Interventions

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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.

Locations (106)

Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site

Rosario Santa Fe, Argentina

Novartis Investigative Site

New South Wales, Australia

Novartis Investigative Site

Perth, Australia

Novartis Investigative Site

South Australia, Australia

Novartis Investigative Site

Outcomes

Primary Outcomes

Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy.

Bone Mineral Density (g/cm\^2) of the Lumbar Spine (L2-L4) as measured by energy x-ray absorptiometry (DXA).

Time frame: Baseline, 12 months

Secondary Outcomes

Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 2, 3, 4 and 5 Years of Therapy.

Bone Mineral Density (g/cm\^2) of the Lumbar Spine (L2-L4) as measured by dual energy x-ray absorptiometry (DXA)

Time frame: Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.

Percentage Change in Bone Mineral Density (BMD)of the Lumbar Spine (L1-L4) Over 5 Years of Therapy.

Bone Mineral Density (g/cm\^2) of the Lumbar Spine (L1-L4)as measured by dual energy x-ray absorptiometry (DXA)

Time frame: Baseline, 5 years.

Percentage Change in Bone Mineral Density (BMD) of the Total Hip at 12 Months, 2 Years, 3 Years, 4 Years and 5 Years After Therapy.

Bone Mineral Density (g/cm\^2) of the Lumbar Spine (L2-L4) as measured by dual energy x-ray absorptiometry (DXA)

Time frame: Baseline, 12 months. Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.

Percentage of Participants With Clinical Fractures at 3 Years of Therapy Which Were Not Present at Baseline

At 3 years of therapy the percentage of participants with fractures as detected by X-ray and/ or bone scan.

Time frame: Baseline,3 years