Originally published as JCO Early Release 10.1200/JCO.2008.19.1783 on December 15 2008

This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Hines, S. L. Articles by Perez, E. A. Search for Related Content PubMed PubMed Citation Articles by Hines, S. L. Articles by Perez, E. A. Related Articles Related Editorial Social Bookmarking                            What's this?

Phase III Randomized, Placebo-Controlled, Double-Blind Trial of Risedronate for the Prevention of Bone Loss in Premenopausal Women Undergoing Chemotherapy for Primary Breast Cancer

From the Mayo Clinic Jacksonville, Jacksonville, FL; Mayo Clinic Rochester, Rochester, MN; Illinois Oncology Research Association, Peoria, IL; Michigan Cancer Research Consortium, Ann Arbor, MI; Missouri Valley Cancer Consortium, Omaha, NE; and Saskatchewan Cancer Foundation, Regina, Saskatchewan, Canada.

Corresponding author: Stephanie L. Hines, MD, Mayo Clinic, 4500 San Pablo Rd, Jacksonville, FL 32224; email: hines.stephanie{at}mayo.edu.

Purpose Risedronate prevents bone loss in postmenopausal women. The purpose of this study was to determine whether risedronate prevents bone loss in premenopausal women undergoing chemotherapy for breast cancer.

Patients and Methods Premenopausal women undergoing chemotherapy for breast cancer were treated with oral calcium 600 mg and vitamin D 400 U daily and randomly assigned to receive oral risedronate 35 mg weekly or placebo, with all these therapies beginning within a month of the start of chemotherapy. Most chemotherapy regimens included anthracyclines, taxanes, or cyclophosphamide. Bone mineral density (BMD) was measured at baseline and 1 year. The primary end point was the change in lumbar spine (LS) BMD from baseline to 1 year.

Results A total of 216 women enrolled; 170 women provided BMD data at 1 year. There was no difference in the mean change or percent change in LS BMD between groups, with a loss of 4.3% in the risedronate arm and 5.4% for placebo at 1 year (P = .18). Loss of BMD at the femoral neck and total hip were also similar between treatment groups. Risedronate was well tolerated, with no significant differences in adverse events compared with placebo, except that arthralgias and chest pain were worse in those receiving the placebos.

Conclusion Risedronate did not prevent bone loss in premenopausal women undergoing adjuvant chemotherapy for breast cancer.

Supported in part by Public Health Service Grants No. CA-25224, CA-37404, CA-35113, CA-63848, CA-63849, CA-35267, CA-35431, and CA-35195.

This study was conducted as a collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health.

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

Clinical Trials repository link available on JCO.org.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

Related Editorial

• Bisphosphonates and Bone Turnover in Premenopausal Women Receiving Adjuvant Chemotherapy
  Alexander Paterson and Tom Baker
  JCO 2009 27: 1005-1006 [Full Text]

This article has been cited by other articles:

				A. Paterson and T. Baker Bisphosphonates and Bone Turnover in Premenopausal Women Receiving Adjuvant Chemotherapy J. Clin. Oncol., March 1, 2009; 27(7): 1005 - 1006. [Full Text] [PDF]