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Efficacy and Safety of Zoledronic Acid ( Every 4 Weeks vs. Every 12 Weeks) in Patients With Documented Bone Metastases From Bone Cancer

This study is currently recruiting participants.
Verified March 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00320710
First received: April 28, 2006
Last updated: March 22, 2013
Last verified: March 2013
History of Changes
  Purpose

Clinical trial in breast cancer patients with bone metastases pretreated with zoledronic acid. Looking at the effectiveness of giving zoledronic acid every 4 weeks versus every 12 weeks given over 1 year. This study is prospective, double-blind, stratified, multi-center, and two-arm.


Condition Intervention Phase
Breast Cancer
 Drug: Zometa® (zoledronic acid)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-blind, Stratified, Multi-center, 2-arm Trial of the Continued Efficacy and Safety of Zoledronic Acid (Every 4 Weeks vs. Every 12 Weeks) in Patients With Documented Bone Metastases From Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Proportion of patients who experience at least one Skeletal Related Event (SRE) during the study period (SRE rate) [ Time Frame: during the study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first skeletal related event(SRE),defined as time(in days)from randomization to first occurrence of any SRE up to wk 52 in the study.SRE includes:pathologic bone fracture,radiation therapy/surgery to bone,spinal cord compression. [ Time Frame: during the study period ] [ Designated as safety issue: No ]
  • Time to first individual type of SRE [ Time Frame: during the study period ] [ Designated as safety issue: No ]
  • • Bone pain score, assessed by: • the brief pain inventory (BPI) at visits 2,3,4,5,8,11 and end of study (EOS) visits • numerical rating scale weekly through month 4 via the touch-tone telephone system (IVRS) [ Time Frame: during the study period ] [ Designated as safety issue: No ]
  • • Urinary N-Tx/Cr ratio and serum bone specific alkaline phosphatase assessed at baseline and monthly through week 48. [ Time Frame: during the study period ] [ Designated as safety issue: No ]
  • Safety comparisons between the two study groups [ Time Frame: during the study perion ] [ Designated as safety issue: No ]

Estimated Enrollment: 423
Study Start Date: February 2006
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zometa® q 4 weeks Drug: Zometa® (zoledronic acid)
Experimental: Zometa® q12 weeks Drug: Zometa® (zoledronic acid)

  Eligibility

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

Inclusion Criteria:

  • Female patients ≥ 18 years of age
  • Confirmed breast cancer with bone metastasis.
  • Pretreated with Zometa®, or Aredia (pamidronate) or all sequential regimens of both, for a minimum of 9 doses.

Exclusion Criteria:

  • Abnormal kidney function determined by serum creatinine levels.
  • Current active dental problems including: ongoing infection of the teeth or jawbone; current exposed bone in the mouth; and current or prior diagnosis of osteonecrosis of the jaw.
  • Recent (within 8 weeks) or planned dental or jaw surgery (e.g., extraction, implants)
  • Diagnosis of metabolic bone disease other than osteoporosis (e.g., Paget's disease of bone)
  • Known hypersensitivity to Zometa
  • Treatment with other investigational drugs within 30 days prior to randomization.

Other protocol-defined exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00320710

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 162 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.  This link exits the ClinicalTrials.gov site
Breast Cancer  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00320710     History of Changes
Other Study ID Numbers: CZOL446E2352
Study First Received: April 28, 2006
Last Updated: March 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Breast cancer
zoledronic acid
bone metastases

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
 Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013