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
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ClinicalTrials.gov Identifier: NCT00320710 |
Recruitment Status :
Completed
First Posted : May 3, 2006
Results First Posted : August 4, 2014
Last Update Posted : August 22, 2014
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer | Drug: Zoledronic acid Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 416 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, 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 in the 2nd Year of Treatment in Patients With Documented Bone Metastases From Breast Cancer |
Study Start Date : | February 2006 |
Actual Primary Completion Date : | July 2013 |
Actual Study Completion Date : | July 2013 |
Arm | Intervention/treatment |
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Experimental: Zoledronic acid every (q) 4 weeks
Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
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Drug: Zoledronic acid
4mg IV
Other Names:
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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.
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Drug: Zoledronic acid
4mg IV
Other Names:
Drug: Placebo Placebo to zoledronic acid |
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.
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Drug: Zoledronic acid
4mg IV
Other Names:
Drug: Placebo Placebo to zoledronic acid |
- Proportion of Patients Who Experienced at Least One Skeletal Related Event (SRE) [ Time Frame: 52 weeks ]An SRE was defined as a pathologic fracture (vertebral and non-vertebral), spinal cord compression, radiation to bone or surgery to bone.
- Time to First SRE [ Time Frame: 52 weeks ]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 ]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 ]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 BPI composite score, which was calculated as the average of items 3, 4, 5 and 6 (worst pain, least pain, average pain and pain right now), ranged from 0 (best possible outcome, no pain) to 10 (worst possible outcome, pain as bad as you can imagine). A positive change from baseline indicates worsening.
- Change From Baseline in Mean Analgesic Score [ Time Frame: baseline, 52 weeks ]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 worsening.
- Change From Baseline in Urinary N-telopeptide / Creatinine Ratio [ Time Frame: baseline, 48 weeks ]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 ]Serum samples were collected to obtain bone specific alkaline phosphatase values.
- Skeletal Morbidity Rate [ Time Frame: 52 weeks ]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).
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.
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): NCT00320710
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00320710 |
Other Study ID Numbers: |
CZOL446E2352 |
First Posted: | May 3, 2006 Key Record Dates |
Results First Posted: | August 4, 2014 |
Last Update Posted: | August 22, 2014 |
Last Verified: | August 2014 |
Breast cancer zoledronic acid bone metastases |
Breast Neoplasms Neoplasm Metastasis Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Neoplastic Processes Pathologic Processes Zoledronic Acid Bone Density Conservation Agents Physiological Effects of Drugs |