Continued Efficacy and Safety of Zoledronic Acid (q 4 Wks vs. q 12 Wks) in the 2nd Year of Treatment in Patients With Bone Metastases From Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00320710
First received: April 28, 2006
Last updated: July 8, 2014
Last verified: July 2014

April 28, 2006
July 8, 2014
February 2006
July 2013   (final data collection date for primary outcome measure)
Proportion of Patients Who Experienced at Least One Skeletal Related Event (SRE) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
An SRE was defined as a pathologic fracture (vertebral and non-vertebral), spinal cord compression, radiation to bone or surgery to bone.
Not Provided
Complete list of historical versions of study NCT00320710 on ClinicalTrials.gov Archive Site
  • Time to First SRE [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    An SRE was defined as a pathologic bone fracture (vertebral and non-vertebral), spinal cord compression, radiation to bone, or surgery to bone. The time to first individual SRE was defined as the date of randomization to the date of first occurrence of any SRE.
  • Time to First Individual Type of SRE [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Types of SREs analyzed were pathologic fractures (vertebral and non-vertebral), spinal cord compression, radiation to bone and surgery to bone. The time to first indvidual SRE was defined as the date of randomization to the date of the first occurrence of any individual SRE.
  • Change From Baseline in Mean Composite Brief Pain Inventory (BPI) Score [ Time Frame: baseline, 52 weeks ] [ Designated as safety issue: No ]
    Participants completed a BPI short form which is a 9 item self-administered questionnaire used to evaluate the severity of a participant's pain and the impact of this pain on the participant's daily functioning. The participant rates his or her worst, least, average, and current pain intensity, lists current treatments and perceived effectiveness, and rates the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. The composite score was calculated as the average of items 3, 4, 5 and 6 (worst pain, least pain, average pain and pain right now). A positive change from baseline indicates improvement.
  • Change From Baseline in Mean Analgesic Score [ Time Frame: baseline, 52 weeks ] [ Designated as safety issue: No ]
    The analgesic score indicates the types of pain medication used. The scores range as follows: 0 = none medication; 1 = minor analgesics (aspirin, NSAID, acetaminophen, propoxyphene, etc.); 2 = Tranquilizers, antidepressants, muscle relaxants, and steroids; 3 = Mild narcotics (oxycodone, meperidine, codeine, etc.); and 4 = Strong narcotics (morphine, hydromorphone, etc.). A positive change from baseline indicates improvement.
  • Change From Baseline in Urinary N-telopeptide / Creatinine Ratio [ Time Frame: baseline, 48 weeks ] [ Designated as safety issue: No ]
    Urine samples were collected to obtain n-telopeptide and creatinine values.
  • Change From Baseline in Serum Bone Specific Alkaline Phosphatase [ Time Frame: baseline, 48 weeks ] [ Designated as safety issue: No ]
    Serum samples were collected to obtain bone specific alkaline phosphatase values.
  • Skeletal Morbidity Rate [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    An SMR for a patient was defined as the "number of occurrences" of any (or a particular) SRE allowing for only 1 event in any 3-week interval, divided by the "time at risk" in years. The "number of occurrences" and the "time at risk" were counts of SRE and the time from the randomization date. Counting began from randomization in the way that every counted event was followed by a 20-day period during which no SRE was counted, nor was the time counted as "at risk". For example, if a patient had 1 SRE during the study, the "time at risk" was calculated as the total number of days in the study minus the 20-day follow-up period for that SRE. If a patient had no SRE events, the entire study period was counted as "time at risk". This SMR calculation method had the advantage of avoiding multiple counts of possibly interdependent SREs (e.g. having 1 fracture increases the probability of having a subsequent SRE).
Not Provided
Not Provided
Not Provided
 
Continued Efficacy and Safety of Zoledronic Acid (q 4 Wks vs. q 12 Wks) in the 2nd Year of Treatment in Patients With Bone Metastases From Breast 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 in the 2nd Year of Treatment in Patients With Documented Bone Metastases From Breast Cancer

Clinical trial in breast cancer patients with bone metastases pretreated for approximately 1 year with a standard zoledronic acid regimen. Looking at the continued effectiveness and safety 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: Zoledronic acid
    4mg IV
    Other Names:
    • Zoledronate
    • ZOL446
    • Zometa
  • Drug: Placebo
    Placebo to zoledronic acid
  • Experimental: Zoledronic acid every (q) 4 weeks
    Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
    Intervention: Drug: Zoledronic acid
  • Experimental: Zoledronic acid q 12 weeks
    Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
    Interventions:
    • Drug: Zoledronic acid
    • Drug: Placebo
  • Experimental: Placebo / zoledronic acid
    Participants randomized to this arm received placebo but the arm was later dropped and participants in this arm were swithced to the zoledronic acid q 4 weeks according to a study amendment.
    Interventions:
    • Drug: Zoledronic acid
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
416
July 2013
July 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 have applied.

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00320710
CZOL446E2352
Yes
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
July 2014

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