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Randomized Controlled Trial
. 2008 Jun 1;26(16):2644-52.
doi: 10.1200/JCO.2007.15.2967. Epub 2008 Apr 21.

Risedronate prevents bone loss in breast cancer survivors: a 2-year, randomized, double-blind, placebo-controlled clinical trial

Susan L Greenspan  1 , Adam Brufsky, Barry C Lembersky, Rajib Bhattacharya, Karen T Vujevich, Subashan Perera, Susan M Sereika, Victor G Vogel
Affiliations
Randomized Controlled Trial

Risedronate prevents bone loss in breast cancer survivors: a 2-year, randomized, double-blind, placebo-controlled clinical trial

Susan L Greenspan et al. J Clin Oncol. .

Abstract

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.

Trial registration: ClinicalTrials.gov NCT00118508.

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Conflict of interest statement

AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

Although all authors completed the disclosure declaration, the following author(s) indicated a financial or other interest that is relevant to the subject matter under consideration in this article. Certain relationships marked with a “U” are those for which no compensation was received; those relationships marked with a “C” were compensated. For a detailed description of the disclosure categories, or for more information about ASCO’s conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors.

Employment or Leadership Position: None Consultant or Advisory Role: Susan L. Greenspan, Procter and Gamble (C); Victor G. Vogel, Procter and Gamble (C) Stock Ownership: None Honoraria: Susan L. Greenspan, Procter and Gamble; Rajib Bhattacharya, Procter and Gamble Research Funding: Susan L. Greenspan, Procter and Gamble; Rajib Bhattacharya, Procter and Gamble; Victor G. Vogel, Procter and Gamble Expert Testimony: None Other Remuneration: None

Figures

Fig. 1
Fig. 1
Flow diagram of the progress through the phases of the randomized trial.
Fig. 2
Fig. 2
(A) Mean (SE) percent changes in bone mineral density from baseline to 24 months. (B) Mean (SE) percent changes in biochemical markers of bone turnover from baseline to 24 months. (*) P < .05; (**) P < .01 changes from baseline; (†) P < .05; (‡) P < .01 comparison between risedronate and placebo groups.
Fig. 3
Fig. 3
(A) Mean (SE) percent changes in bone mineral density from baseline to 24 months. (B) Mean (SE) percent changes in biochemical markers of bone turnover from baseline to 24 months. (*) P < .05; (**) P < .01 changes from baseline; (†) P < .05; (‡) P < .01 comparison between risedronate plus no aromatase inhibitor (AI) and placebo plus no AI or risedronate plus AI and placebo plus AI groups.
Fig. 4
Fig. 4
(A) Mean (SE) percent change in bone mineral density from baseline to 24 months. (B) Mean (SE) percent change in biochemical markers of bone turnover from baseline to 24 months. (*) P < .05; (**) P < .01 changes from baseline; (†) P < .05; (‡) P < .01 comparison between placebo plus aromatase inhibitor (AI) and risedronate plus AI or placebo plus no AI and risedronate plus no AI groups.
See this image and copyright information in PMC

References

    1. Early Breast Cancer Trialists’ Collaborative Group. Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: An overview of the randomised trials. Lancet. 2005;365:1687–1717. - PubMed
    1. Pfeilschifter J, Diel IJ. Osteoporosis due to cancer treatment: Pathogenesis and management. J Clin Oncol. 2000;18:1570–1593. - PubMed
    1. del Mastro L, Venturini M, Sertoli MR, et al. Amenorrhea induced by adjuvant chemotherapy in early breast cancer patients: Prognostic role and clinical implications. Br Cancer Res Treat. 1997;43:183–190. - PubMed
    1. Schilsky RL, Lewis BJ, Sherins RJ, et al. Gonadal dysfunction in patients receiving chemotherapy for cancer. Ann Intern Med. 1980;93:109–116. - PubMed
    1. Shapiro CL, Manola J, LeBoff M. Ovarian failure after adjuvant chemotherapy is associated with rapid bone loss in women with early-stage breast cancer. J Clin Oncol. 2001;19:3306–3311. - PubMed

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