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document
Zoledronic acid significantly reduces skeletal complications compared with placebo in Japanese women with bone metastases from breast cancer : a randomized , placebo-controlled trial . PURPOSE To investigate the efficacy and safety of zoledronic acid for the treatment of bone metastases from breast cancer . PATIENTS AND METHODS Women with bone metastases ( N = 228 ) were randomly assigned to receive 4 mg zoledronic acid ( n = 114 ) or placebo ( n = 114 ) via 15-minute infusions every 4 weeks for 1 year . The primary efficacy end point was the skeletal-related event ( SRE ) rate ratio between treatment groups . An SRE was defined as pathologic fracture , spinal cord compression , and radiation or surgery to bone . Secondary end points included percentage of patients with at least one SRE , time-to-first SRE , and Andersen-Gill multiple-event analysis . RESULTS The SRE rate ratio at 1 year ( excluding HCM and adjusted for prior fracture ) was 0.61 ( permutation test ; P = .027 ) , indicating that zoledronic acid reduced the rate of SRE by 39 % compared with placebo . The percentage of patients with at least one SRE ( excluding HCM ) was significantly reduced by 20 % by zoledronic acid ( 29.8 % v 49.6 % for placebo ; P = .003 ) . Zoledronic acid significantly delayed time-to-first SRE ( median not reached v 364 days ; Cox regression ; P = .007 ) and reduced the risk of SREs by 41 % in multiple event analysis ( risk ratio = 0.59 ; P = .019 ) compared with placebo . Zoledronic acid was well tolerated with a safety profile similar to placebo . No patient treated with zoledronic acid had grade 3 or 4 serum creatinine increase . CONCLUSION Zoledronic acid significantly reduced skeletal complications compared with placebo across multiple end points in Japanese women with bone metastases from breast cancer .
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Intervention_Pharmacological
Zoledronic acid
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Intervention_Control
placebo
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Intervention_Pharmacological
zoledronic acid
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Intervention_Pharmacological
4 mg zoledronic acid
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Intervention_Control
placebo
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Intervention_Pharmacological
zoledronic acid
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Intervention_Control
placebo .
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Intervention_Pharmacological
Zoledronic acid
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Intervention_Control
placebo .
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Intervention_Pharmacological
Zoledronic acid
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Intervention_Pharmacological
Zoledronic acid
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Intervention_Control
placebo
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Outcome_Physical
SRE rate ratio
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Outcome_Physical
rate of SRE
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Outcome_Physical
percentage of patients with at least one SRE ( excluding HCM )
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Outcome_Physical
significantly delayed time-to-first SRE
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Outcome_Physical
reduced the risk of SREs
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Outcome_Other
tolerated
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Participant_Condition
women
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Participant_Condition
breast cancer
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Participant_Sex
Women
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Participant_Sample-size
N = 228 )