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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00171314
First received: September 12, 2005
Last updated: March 19, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: Zoledronic acid
Drug: Letrozole
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Zoledronic Acid to Prevent Cancer-treatment Bone Loss in Post-menopausal Women Receiving Adjuvant Letrozole for Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percent Change in Lumbar Spine (L2-L4) BMD After 12 Months of Letrozole Therapy [ Time Frame: From Baseline - 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percent Change in Lumbar Spine (L2-L4) BMD at 2 Years, 3 Years, 4 Years and 5 Years [ Time Frame: From Baseline to Year 2, Year 3, Year 4, Year 5 ] [ Designated as safety issue: No ]
    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.

  • Percent Change in Lumbar Spine (L1-L4) BMD at Year 1, Year 2, Year 3, Year 4 and Year 5 [ Time Frame: From Baseline to Year 1, Year 2, Year 3, Year 4, Year 5 ] [ Designated as safety issue: No ]
    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.

  • Percent Change in Total Hip BMD at Year 1, Year 2, Year 3, Year 4 and Year 5 [ Time Frame: From baseline to Year 1, Year 2, Year 3, Year 4, Year 5 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Radiological (Vertebra) Fractures Which Were Not Present at Baseline But Were Present at Year 3 [ Time Frame: Year 3 ] [ Designated as safety issue: No ]
    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.


Enrollment: 527
Study Start Date: March 2004
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Upfront Zoledronic Acid
Zoledronic 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
 Drug: Zoledronic acid
Zoledronic acid 4 mg Intravenous (IV)15 minute infusion every 6 months.
Other Names:
  • ZOL446
  • Zometa®
Drug: Letrozole
Letrozole tablets 2.5 mg/day/taken orally for 5 years.
Other Name: Femara®
Experimental: Delayed Zoledronic Acid
Zoledronic 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
 Drug: Zoledronic acid
Zoledronic acid 4 mg Intravenous (IV)15 minute infusion every 6 months.
Other Names:
  • ZOL446
  • Zometa®
Drug: Letrozole
Letrozole tablets 2.5 mg/day/taken orally for 5 years.
Other Name: Femara®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171314

  Show 49 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00171314     History of Changes
Other Study ID Numbers: CFEM345D2406
Study First Received: September 12, 2005
Results First Received: December 15, 2011
Last Updated: March 19, 2012
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by Novartis:
breast cancer
letrozole
zoledronic acid
adjuvant
postmenopausal

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adjuvants, Immunologic
Letrozole
Zoledronic acid
Diphosphonates
 Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 19, 2013