Risedronate may preserve bone microarchitecture in breast cancer survivors on aromatase inhibitors: A randomized, controlled clinical trial.

Abstract

This study provides preliminary evidence that risedronate not only preserves BMD but may also attenuate the loss of bone microarchitecture over 2years during a time of accelerated bone loss in post-menopausal breast cancer survivors on aromatase inhibitors. Accelerated bone loss and elevated fracture risk are associated with the use of aromatase inhibitors (AIs) in women with breast cancer. We previously reported that the oral bisphosphonate, risedronate, can maintain bone mineral density (BMD) in the hip and spine over 2-years in post-menopausal breast cancer survivors on AIs. In this study, we examined whether oral bisphosphonates can also preserve bone microarchitecture as measured by the trabecular bone score (TBS) in this population. This 2-year randomized, double-blind, placebo-controlled trial included postmenopausal women over age 55 with breast cancer on an AI who had low bone mass. Participants provided informed consent and were randomized to risedronate 35mg once weekly or placebo. We examined 12- and 24-month changes in spine TBS, analyzed using linear mixed models. One-hundred and nine women with a mean age of 70.5years were included in the analysis. In the placebo group, BMD declined at the spine and hip over the 24-month period but was preserved in the active treatment group (data previously reported). TBS declined in the placebo group by -2.1% and -2.3% at 12- and 24-months, respectively (p<0.005). The TBS percent change in bisphosphonate-treated patients was -0.9% and -1.3% at 12 and 24-months but did not reach statistical significance (p=0.24 and 0.14). The 12- and 24-month between-group differences were 0.9 (p=0.38) and 0.8 (p=0.44) percentage points. TBS change correlated with spine BMD changes in the placebo group at 12- and 24-months (r=0.33 and 0.34, p<0.01) but not in the active treatment group. The oral bisphosphonate risedronate preserves BMD and may attenuate loss of bone microarchitecture over 2years during a time of accelerated bone loss in breast cancer survivors on AIs, but more definitive evidence is needed.