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This version published online on March 15, 2005
Journal of Clinical Endocrinology & Metabolism, doi:10.1210/jc.2004-1444
A more recent version of this article appeared on June 1, 2005
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Submitted on July 22, 2004
Accepted on March 8, 2005

PAMIDRONATE IN THE PREVENTION OF CHEMOTHERAPY-INDUCED BONE LOSS IN PREMENOPAUSAL WOMEN WITH BREAST CANCER: A RANDOMIZED CONTROLLED TRIAL

Ghada El-Hajj Fuleihan MD, MPH*, Mariana Salamoun BS, BA, Yasser Abou Mourad MD, Aref Chehal MD, Ziad Salem MD, Ziyad Mahfoud PhD, and Ali Shamseddine MD

Calcium Metabolism and Osteoporosis Program, Division of Endocrinology; Division of Hematology Onconlogy, Schoool of Medicine; Department of Epidemiology and Population Health, School of Health Sciences; American University of Beirut-Medical Center, Lebanon

* To whom correspondence should be addressed. E-mail: gf01{at}aub.edu.lb.

Purpose: Mortality from breast cancer has decreased in large part due to adjuvant chemotherapy. Sequalae of therapy include ovarian failure and bone loss, loss that would increase these patients' risk of fracture with aging. In this study we assessed the efficacy of pamidronate in preventing such loss.

Patients and Methods: one year randomized, double-blind, placebo-controlled trial comparing pamidronate 60 mg intravenously every three months with placebo in 40 pre-menopausal women with newly diagnosed breast cancer. Bone mineral density (BMD) of the spine and hip and remodeling markers were monitored over one year.

Results: Over half of subjects became amenorrheic, and those who did were 4 yr older than those who did not (P = 0.02). The mean difference in % change BMD at 12 months between the two treatment groups in the overall study group was 5.1% at the lumbar spine (P = 0.002); and it was 5% at the lumbar spine and 5.% at the total hip in the amenorrheic subgroup (P < 0.03). Biochemical markers of bone remodeling did not differ between the two treatment groups and teatment was well tolerated.

Conclusion: Chemotherapy-induced amenorrhea is common with ensuing bone loss at the spine and hip. Pamidronate prevented bone loss at the spine and hip and was well tolerated.
Key words: Pamidronate • bone loss • breast cancer • pre menopausal women




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