Effect of denosumab on bone mineral density in women receiving adjuvant aromatase inhibitors for non-metastatic breast cancer: subgroup analyses of a phase 3 study

  • Georgiana K. Ellis
  • Henry G. Bone
  • Rowan Chlebowski
  • Devchand Paul
  • Silvana Spadafora
  • Michelle Fan
  • Dennis Kim
Clinical Trial

Abstract

Denosumab increased lumbar spine bone mineral density (BMD) versus placebo in a 2-year, randomized, placebo-controlled, phase 3 study of patients with hormone-receptor-positive, non-metastatic breast cancer and low bone mass who were receiving adjuvant aromatase inhibitor therapy. In subgroup analyses at 12 and 24 months, we evaluated factors (duration and type of aromatase inhibitor, tamoxifen use, age, time since menopause, body mass index, T-score) that might influence BMD at the lumbar spine, total hip, femoral neck, and 1/3 radius. Patients were randomized to receive placebo (= 125) or 60 mg denosumab (= 127) subcutaneously every 6 months. In all subgroups, 12 or 24 months’ treatment with denosumab was associated with larger BMD gains than placebo across multiple skeletal sites. Most increases were statistically significant (< 0.05). Twice-yearly administration of denosumab, regardless of patient subgroup or skeletal site, resulted in consistent increases in BMD versus placebo at 12 and 24 months.

Keywords

RANKL Denosumab Clinical trial Cancer treatment-induced bone loss Breast cancer 

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Copyright information

© Springer Science+Business Media, LLC. 2009

Authors and Affiliations

  • Georgiana K. Ellis
    • 1
  • Henry G. Bone
    • 2
  • Rowan Chlebowski
    • 3
  • Devchand Paul
    • 4
    • 5
  • Silvana Spadafora
    • 6
  • Michelle Fan
    • 7
  • Dennis Kim
    • 7
  1. 1.Seattle Cancer Care AllianceSeattleUSA
  2. 2.Michigan Bone & Mineral ClinicDetroitUSA
  3. 3.UCLA Medical CenterTorranceUSA
  4. 4.US OncologyHoustonUSA
  5. 5.Rocky Mountain Cancer CentersDenverUSA
  6. 6.Algoma Regional Cancer ProgramSault Ste. MarieCanada
  7. 7.Amgen Inc.Thousand OaksUSA

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