• Georgiana K Ellis, Henry G Bone, Rowan Chlebowski, Devchand Paul, Silvana Spadafora, Michelle Fan, and Dennis Kim.
• Seattle Cancer Care Alliance, 825 Eastlake Avenue East, Mail Stop G3-200, Seattle, WA, 98109-1023, USA. gellis@u.washington.edu
• Breast Cancer Res. Treat. 2009 Nov 1; 118 (1): 81-7.

AbstractDenosumab 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 (n = 125) or 60 mg denosumab (n = 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 (P < 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.

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