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Zoledronic acid prevents bone loss in premenopausal women with early breast cancer undergoing adjuvant chemotherapy: a phase III trial of the Korean Cancer Study Group (KCSG-BR06-01)

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Abstract

To determine whether zoledronic acid (ZA) can prevent bone loss in premenopausal women undergoing adjuvant chemotherapy for breast cancer. In this randomized, open-label, phase III multicenter trial, premenopausal women >40 years were randomly assigned to ZA treatment (4 mg IV, every 6 months) or observation after surgery. All patients were treated with four cycles of AC followed by four cycles of taxane. Between March 2007 and May 2008, we assessed a total of 112 premenopausal women, all of whom developed amenorrhea at 1 year after chemotherapy. The mean percent change of BMD in the lumbar spine (LS) was −1.1% in the ZA group versus −7.5% in observation group at 12 months. Differences in percent change of BMD from baseline between the two groups were 6.4% for the LS, and 3.6% for the femoral neck. The mean levels of bone turnover at 12 months were significantly lower in the ZA group. ZA was generally well tolerated. Infusion of ZA 4 mg every 6 months effectively prevented bone loss within the first year in premenopausal women receiving adjuvant chemotherapy for early breast cancer. Regular BMD measurements and early bisphosphonate therapy should be considered in these patients.

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Acknowledgment

This study was supported by a grant of the Korean Health 21 R&D Project, Ministry of Health and Welfare, Republic of Korea (0412-CR01-0704-001).

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Authors and Affiliations

  1. Division of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Asanbyeongwon-gil 86, Songpa-gu, Seoul, 138-736, Korea

    Jeong Eun Kim, Jin-Hee Ahn, Kyung Hae Jung & Sung-Bae Kim

  2. Department of Clinical Statistics and Epidemiology, Asan Medical Center, Seoul, Korea

    Hwa Jung Kim

  3. National Cancer Center, Seoul, Korea

    Keun-Suk Lee & Jung-Sil Ro

  4. Samsung Medical Center, Seoul, Korea

    Yun-Hee Park, Jin-Suk Ahn & Young-Hyk Im

  5. Seoul National University Hospital, Seoul, Korea

    Seock-Ah Im

  6. Inha University, Seoul, Korea

    Moon-Hee Lee

  7. Kyung-Hee University, Seoul, Korea

    Si-Young Kim

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  1. Jeong Eun Kim
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Correspondence to Jin-Hee Ahn.

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Kim, J.E., Ahn, JH., Jung, K.H. et al. Zoledronic acid prevents bone loss in premenopausal women with early breast cancer undergoing adjuvant chemotherapy: a phase III trial of the Korean Cancer Study Group (KCSG-BR06-01). Breast Cancer Res Treat 125, 99–106 (2011). https://doi.org/10.1007/s10549-010-1201-8

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  • DOI: https://doi.org/10.1007/s10549-010-1201-8

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