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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

April 28, 2006
March 22, 2013
February 2006
September 2013   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00320710 on ClinicalTrials.gov Archive Site
  • 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 ]
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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
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Breast Cancer
Drug: Zometa® (zoledronic acid)
  • Experimental: Zometa® q 4 weeks
    Intervention: Drug: Zometa® (zoledronic acid)
  • Experimental: Zometa® q12 weeks
    Intervention: Drug: Zometa® (zoledronic acid)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
423
September 2013
September 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals
United States,   Puerto Rico
 
NCT00320710
CZOL446E2352
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP