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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

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ClinicalTrials.gov Identifier: NCT00171314
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : April 11, 2012
Last Update Posted : April 11, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: Zoledronic acid Drug: Letrozole Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 527 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2004
Actual Primary Completion Date : November 2010

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U.S. FDA Resources

Arm Intervention/treatment
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®



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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.


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): NCT00171314


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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00171314     History of Changes
Other Study ID Numbers: CFEM345D2406
First Posted: September 15, 2005    Key Record Dates
Results First Posted: April 11, 2012
Last Update Posted: April 11, 2012
Last Verified: March 2012

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin 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