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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00171340
First Posted: September 15, 2005
Last Update Posted: April 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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
Bone Loss Breast Cancer Drug: Zoledronic acid Drug: Letrozole Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, MultiCenter Study to Evaluate the Use of Zolendronic Acid in the Prevention of Cancer Treatment-Related Bone Loss in Postmenopausal Women With Estrogen Positive and/or Progesterone Positive Breast Cancer Receiving Letrozole as Adjuvant Therapy

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy. [ Time Frame: Baseline, 12 months ]
    Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by energy x-ray absorptiometry (DXA).


Secondary Outcome Measures:
  • Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 2, 3, 4 and 5 Years of Therapy. [ Time Frame: Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years. ]
    Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by dual energy x-ray absorptiometry (DXA)

  • Percentage Change in Bone Mineral Density (BMD)of the Lumbar Spine (L1-L4) Over 5 Years of Therapy. [ Time Frame: Baseline, 5 years. ]
    Bone Mineral Density (g/cm^2) of the Lumbar Spine (L1-L4)as measured by dual energy x-ray absorptiometry (DXA)

  • 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. [ Time Frame: Baseline, 12 months. Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years. ]
    Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by dual energy x-ray absorptiometry (DXA)

  • Percentage of Participants With Clinical Fractures at 3 Years of Therapy Which Were Not Present at Baseline [ Time Frame: Baseline,3 years ]
    At 3 years of therapy the percentage of participants with fractures as detected by X-ray and/ or bone scan.


Enrollment: 1065
Study Start Date: May 2003
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Upfront Zoledronic Acid
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.
Drug: Zoledronic acid
Zolendronic 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
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.
Drug: Zoledronic acid
Zolendronic 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171340


  Show 106 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00171340     History of Changes
Other Study ID Numbers: CFEM345D2405
First Submitted: September 12, 2005
First Posted: September 15, 2005
Results First Submitted: March 22, 2011
Results First Posted: May 26, 2011
Last Update Posted: April 16, 2012
Last Verified: April 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Bone Loss
Osteopenia
Breast cancer
letrozole
zoledronic acid
postmenopausal

Additional relevant MeSH terms:
Breast Neoplasms
Bone Diseases, Metabolic
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Letrozole
Zoledronic acid
Diphosphonates
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents