Last reviewed · How we verify
A Prospective, Randomized, Multi-center Comparative 2-arm Trial of Efficacy and Safety of Zoledronic Acid (Every 3-months vs. Every 4 Weeks) Beyond Approximately 1 Year of Treatment With Zoledronic Acid in Patients With Bone Lesions From Breast Cancer
The objective of this study is to assess the clinical benefit of two different dosing schedules of zoledronic acid in patients with metastatic bone lesions from breast cancer who have already been treated with zoledronic acid for about one year.
Details
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 430 |
| Start date | 2006-02 |
Conditions
- Breast Cancer With Bone Metastasis
Interventions
- Zoledronic acid
Primary outcomes
- Annual Overall Skeletal Morbidity Rate (SMR) — 12 months
The SMR was computed by summing all Skeletal Related Event(s) (SREs)which occurred during the observation period and dividing it by the ratio "days of observation period / 365.25", for each participant. SRE was defined as: pathologic bone fracture, spinal cord compression, surgery to bone both curative and prophylactic, radiation therapy to bone, or hypercalcemia of malignancy. SMR (years) = 365.25 x SMR(days) where SMR (days) = total number of SREs / total SRE risk period (days). Risk period for SMR was computed as the days from randomization date to the date of last visit.
Countries
Italy