Clinical Trial

Breast Cancer Research and Treatment

, 118:81

First online:

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. EllisAffiliated withSeattle Cancer Care Alliance Email author 
  • , Henry G. BoneAffiliated withMichigan Bone & Mineral Clinic
  • , Rowan ChlebowskiAffiliated withUCLA Medical Center
  • , Devchand PaulAffiliated withUS OncologyRocky Mountain Cancer Centers
  • , Silvana SpadaforaAffiliated withAlgoma Regional Cancer Program
  • , Michelle FanAffiliated withAmgen Inc.
  • , Dennis KimAffiliated withAmgen Inc.

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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