Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 26, No 15S (May 20 Supplement), 2008: 525
© 2008 American Society of Clinical Oncology

This Article Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Download to citation manager Rights & Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Hines, S. L. Articles by Perez, E. A. Search for Related Content PubMed Articles by Hines, S. L. Articles by Perez, E. A.

Abstract

N02C1: A phase III randomized, placebo-controlled, double-blind trial of risedronate for prevention of bone loss in premenopausal women undergoing adjuvant chemotherapy for breast cancer (BC)

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

525

Background: Risedronate is used for preventing postmenopausal osteoporosis. Its effect in preventing bone loss in premenopausal women undergoing chemotherapy for BC is unknown. Methods: A randomized, placebo controlled, double blind phase III trial assessed the effect of risedronate in premenopausal women undergoing adjuvant chemotherapy for BC (Stage I-IIIB). Women 18 years were randomized to risedronate 35 mg weekly or placebo for 1 year; all pts received daily calcium 600 mg/vitamin D 400 units. Chemotherapy regimens included anthracyclines, taxanes, cyclophosphamide, methotrexate, or fluorouracil, with a mean duration of 146 days. Patients were stratified by tamoxifen, taxane use, time from last menses, and age. The primary endpoint was the change in lumbar spine bone mineral density (BMD) from baseline to 1 year. A two-sided two-sample t-test with 200 patients had 80% power to detect a 5% difference in the change over 12 months between treatment groups with a 5% Type I error rate. Linear regression modeling of the BMD at 1 year was used to adjust for covariates. Results: 216 women enrolled. 154 completed treatment. There was no difference in mean BMD change at 1 year vs. placebo (Table) and no difference in success rates (increase in BMD) between arms (p =0.43). Regression modeling confirmed no treatment effect (p=0.13) when controlled for baseline BMD and tamoxifen. No significant differences in adverse events were noted, except that arthralgias and chest pain were worse with placebo p=0.04). Conclusions: Risedronate did not prevent bone loss in premenopausal women undergoing adjuvant chemotherapy for BC. We gratefully acknowledge support from Aventis, Proctor & Gamble, and NCCTG (NIH CA25224) for this study.

Author Disclosure

Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Aventis

Abstract presentation from the 2008 ASCO Annual Meeting