Conditions: Breast Cancer
Keywords: Breast cancer zoledronic acid bone metastases
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 416
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks. arm 2: 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. arm 3: 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: intervention 1: Zoledronic acid intervention 2: Placebo
Intervention descriptions: intervention 1: 4mg IV intervention 2: Placebo to zoledronic acid

Protocol document: