title: Randomized trial of adjuvant zoledronic acid in postmenopausal women with high-risk breast cancer.
abstract: OBJECTIVE
  We present the results of a randomized multicenter clinical trial of adjuvant zoledronic acid (ZA) in postmenopausal women with high-risk breast cancer. The primary objective was change in bone mineral density (BMD) at the lumbar spine and femoral neck at 1 year. Secondary objectives included change in calcaneal BMD, disease-free survival (DFS), overall survival (OS), and toxicity.
  
  
  METHODS
  Postmenopausal women with stage II/III breast cancer diagnosed up to 5 years previous were eligible and randomized to either observation or ZA 4 mg intravenous every 3 months. Bone mineral density testing was performed at 0, 6, and 12 months.
  
  
  RESULTS
  Sixty-eight women were enrolled (36 ZA and 32 observation). The population was a median of 2 years from diagnosis and the majority received tamoxifen during the study. There was a significant difference in the mean change from baseline to 1 year follow-up for lumbar spine (increased by 4.28% ± 0.62%; P = .01), total femur (increased by 1.9% ± 0.4%; P = .03), trochanter (increased by 2.97% ± 0.69%; P = .03), and calcaneal BMD (increased by 2% ± 0.57%; P = .01) in favor of the ZA arm. No significant difference in the mean change for the femoral neck was seen. No significant differences in DFS or OS were observed.
  
  
  CONCLUSIONS
  Zoledronic acid significantly improved the BMD at multiple skeletal sites in postmenopausal women largely on tamoxifen. No new safety signals were noted. There were insufficient events to comment on DFS or OS.
authors.affiliation: University of Wisconsin Comprehensive Cancer Center, 1111 Highland Avenue, Madison, WI 53705, USA.
authors.forename: Ticiana
authors.initials: T
authors.lastname: Leal
authors.forename: Amyé
authors.initials: A
authors.lastname: Tevaarwerk
authors.forename: Richard
authors.initials: R
authors.lastname: Love
authors.forename: James
authors.initials: J
authors.lastname: Stewart
authors.forename: Neil
authors.initials: N
authors.lastname: Binkley
authors.forename: Jens
authors.initials: J
authors.lastname: Eickhoff
authors.forename: Benjamin
authors.initials: B
authors.lastname: Parrot
authors.forename: Daniel
authors.initials: D
authors.lastname: Mulkerin
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D002111:Calcaneus / Q000187:drug effects; D017024:Chemotherapy, Adjuvant; D004164:Diphosphonates / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D005272:Femur Neck / Q000187:drug effects; D005500:Follow-Up Studies; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D008159:Lumbar Vertebrae / Q000187:drug effects; D008875:Middle Aged; D009367:Neoplasm Staging; D017698:Postmenopause; D012307:Risk Factors; D016019:Survival Analysis; D013629:Tamoxifen / Q000627:therapeutic use; D016896:Treatment Outcome; D000077211:Zoledronic Acid
chemical_list: D018931:Antineoplastic Agents, Hormonal; D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D013629:Tamoxifen; D000077211:Zoledronic Acid