Risedronate prevents bone loss in breast cancer survivors: a 2-year, randomized, double-blind, placebo-controlled clinical trial.
OBJECTIVE
Limited data are available on the efficacy of oral bisphosphonate therapy in breast cancer survivors. Our goal was to examine prevention of breast cancer-related bone loss in this cohort.


METHODS
Eighty-seven postmenopausal women after chemotherapy for breast cancer were randomly assigned to once-weekly risedronate 35 mg or placebo for 24 months. Outcomes included bone mineral density (BMD) and turnover markers.


RESULTS
At study initiation, 13% of patients were on an aromatase inhibitor (AI). After 24 months, there were differences of 1.6 to 2.5% (P < .05) at the spine and hip BMD between the placebo and risedronate groups. At study completion, 44% were on an AI. Adjusting for an AI, women on placebo plus AI had a decrease in BMD of (mean +/- SE) 4.8% +/- 0.8% at the spine and 2.8% +/- 0.5% at the total hip (both P < .001). In women on risedronate + AI, the spine decreased by 2.4% +/- 1.1% (P < .05) and was stable at the hip. Women in the placebo group not on an AI, maintained BMD at the spine, and had a 1.2% +/- 0.5% loss at the total hip (P < .05). Women who received risedronate but no AI had the greatest improvement in BMD of 2.2% +/- 0.9% (P < .05) at the total hip. Bone turnover was reduced with risedronate. There were no differences in adverse events between the groups.


CONCLUSIONS
We conclude that in postmenopausal women with breast cancer with or without AI therapy, once-weekly oral risedronate was beneficial for spine and hip BMD, reduced bone turnover, and was well tolerated.
Greenspan
Susan L
SL
Department of Medicine, University of Pittsburgh, 3471 Fifth Ave, Kaufmann Suite 1110, Pittsburgh, PA 15213, USA. greenspans@dom.pitt.edu
Brufsky
Adam
A
Lembersky
Barry C
BC
Bhattacharya
Rajib
R
Vujevich
Karen T
KT
Perera
Subashan
S
Sereika
Susan M
SM
Vogel
Victor G
VG
D047072:Aromatase Inhibitors / Q000627:therapeutic use*; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000150:complications* / Q000188:drug therapy / Q000601:surgery; D002136:Calcium, Dietary / Q000008:administration & dosage*; D004311:Double-Blind Method; D012968:Etidronic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000209:etiology / Q000517:prevention & control*; D000068296:Risedronic Acid
D047072:Aromatase Inhibitors; D050071:Bone Density Conservation Agents; D002136:Calcium, Dietary; D000068296:Risedronic Acid; D012968:Etidronic Acid