ClinicalTrials.Veeva

Menu

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

Novartis logo

Novartis

Status and phase

Completed
Phase 3

Conditions

Breast Cancer
Bone Loss

Treatments

Drug: Zoledronic acid
Drug: Letrozole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00171340
CFEM345D2405

Details and patient eligibility

About

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.

Enrollment

1,065 patients

Sex

Female

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,065 participants in 2 patient groups

Upfront Zoledronic Acid
Experimental group
Description:
Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
Treatment:
Drug: Letrozole
Drug: Zoledronic acid
Delayed Zoledronic Acid
Experimental group
Description:
Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score \<= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
Treatment:
Drug: Letrozole
Drug: Zoledronic acid

Trial contacts and locations

106

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems