Originally published as JCO Early Release 10.1200/JCO.2007.15.2967 on April 21 2008

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Risedronate Prevents Bone Loss in Breast Cancer Survivors: A 2-Year, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Susan L. Greenspan, Adam Brufsky, Barry C. Lembersky, Rajib Bhattacharya, Karen T. Vujevich, Subashan Perera, Susan M. Sereika, Victor G. Vogel

From the University of Pittsburgh, Department of Medicine, Magee Womens Hospital/University of Pittsburgh Breast Program; University of Pittsburgh Medical Center Hillman Cancer Center; Departments of Medicine, Biostatistics, Health and Community Systems, Biostatistics, and Epidemiology, University of Pittsburgh, Pittsburgh, PA; and the Department of Medicine, University of Kansas, Kansas City, KS

Corresponding author: Susan L. Greenspan, MD, University of Pittsburgh, 3471 Fifth Ave, Kaufmann Suite 1110, Pittsburgh, PA 15213; e-mail: greenspans{at}dom.pitt.edu

Purpose: 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.

Patients and 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.

Conclusion: 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.

published online ahead of print at www.jco.org on April 21, 2008.

Supported by the National Institutes of Health (NIH)/National Institute of Diabetes and Digestive and Kidney Diseases (Grant No. K24 DK062895-03), a Procter and Gamble and Sanofi-aventis noncompany-sponsored trial grant, and the University of Pittsburgh Montefiore University Hospital Clinical Translational Research Center (NIH/National Center for Research Resources [NCRR]/Clinical Translational Science Institute Grant No. UL1 RR024153 and NIH/NCRR/GCRC Grant No. M01RR000056).

This study appears in the ClinicalTrials.gov registry with the identifier NCT00118508 [ClinicalTrials.gov] .

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: NCT00118508 [ClinicalTrials.gov] .