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
Source: ClinicalTrials.gov NCT00320710 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Who Experienced at Least One Skeletal Related Event (SRE) |
22; 23.2 | — |
| SECONDARY Time to First SRE |
NA; NA | — |
| SECONDARY Time to First Individual Type of SRE |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Change From Baseline in Mean Composite Brief Pain Inventory (BPI) Score |
0.24; 0.31 | — |
| SECONDARY Change From Baseline in Mean Analgesic Score |
0.5; 0.5 | — |
| SECONDARY Change From Baseline in Urinary N-telopeptide / Creatinine Ratio |
10.612; 14.697 | — |
| SECONDARY Change From Baseline in Serum Bone Specific Alkaline Phosphatase |
0.797; 4.514 | — |
| SECONDARY Skeletal Morbidity Rate |
0.46; 0.50 | — |
Eligibility 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 have applied.
Data sourced from ClinicalTrials.gov (NCT00320710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.