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Completed

NCT Number: NCT00171314

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zoledronic acid

Drug

Zoledronic acid 4 mg Intravenous (IV)15 minute infusion every 6 months.

Other names: ZOL446, Zometa®

letrozole

Drug

Letrozole tablets 2.5 mg/day/taken orally for 5 years.

Other names: Femara®

Primary outcomes

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

    Time frame: From Baseline - 12 months

    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 outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2004
Primary completion
2010
First posted
Sep 15, 2005
Registry last updated
Apr 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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