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document
Efficacy and safety of zoledronic acid in patients with breast cancer metastatic to bone : a multicenter clinical trial . PURPOSE This study evaluated the efficacy and safety of zoledronic acid in breast cancer patients with newly diagnosed bone metastases . MATERIALS AND METHODS Patients diagnosed with bone metastases < or = 6 weeks prior to first visit were enrolled . Zoledronic acid ( 4 mg ) was administered via a 15-minute infusion every 3 or 4 weeks for 12 infusions . Skeletal-related events ( SREs ) were defined as pathologic bone fractures , spinal cord compression , surgery to bone , radiation therapy to bone , and hypercalcemia of malignancy . Primary efficacy end points were the proportion of patients with at least one SRE and the time to first SRE . Secondary end points included pain , analgesic use , and quality of life . RESULTS Among 312 patients enrolled , 30 % experienced at least one SRE during the 12-month study , and 22 % experienced only one SRE . The median time to first SRE was not reached in the intent-to-treat population . Mean pain and analgesic scores declined from baseline , and quality-of-life scores remained stable to study end . The most frequently reported adverse events , regardless of relationship to study drug , were pyrexia ( 22 % ) and bone pain ( 10 % ) . Serum creatinine levels did not significantly increase from baseline throughout the study . CONCLUSIONS Breast cancer patients with newly diagnosed bone metastases who were treated with zoledronic acid had a low incidence of SREs compared with patients who received placebo in randomized phase III trials , and pain was decreased from baseline . This study demonstrated the favorable risk : benefit ratio of zoledronic acid for the prevention of skeletal complications .
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Intervention_Pharmacological
zoledronic acid
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Intervention_Pharmacological
zoledronic acid
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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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Intervention_Pharmacological
zoledronic acid
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Outcome_Other
efficacy and safety
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Outcome_Physical
Skeletal-related events ( SREs )
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Outcome_Pain
pain
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Outcome_Other
analgesic use
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Outcome_Physical
quality of life
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Outcome_Physical
SRE
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Outcome_Physical
SRE
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Outcome_Physical
SRE
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Outcome_Pain
Mean pain
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Outcome_Other
analgesic scores
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Outcome_Physical
quality-of-life scores remained stable
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Outcome_Adverse-effects
pyrexia
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Outcome_Adverse-effects
bone pain
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Outcome_Physical
Serum creatinine levels
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Outcome_Physical
SREs
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Participant_Condition
breast cancer
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Participant_Condition
breast cancer
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Participant_Condition
bone metastases
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Participant_Condition
bone metastases
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Participant_Sample-size
312
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Participant_Condition
Breast cancer
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Participant_Condition
bone metastases