Management of anastrozole-induced bone loss in breast cancer patients with oral risedronate: results from the ARBI prospective clinical trial

The aim of this multicenter, phase III, prospective open label clinical trial was to investigate the effect of risedronate (R) on bone mineral density (BMD) in postmenopausal, early breast cancer (BC) patients scheduled to receive anastrozole (A). Pre-treatment BMD of 213 patients with hormone recep...

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Published in:	Breast cancer research : BCR Vol. 12; no. 2; p. R24
Main Authors:	Markopoulos, Christos, Tzoracoleftherakis, Evagelos, Polychronis, Athanassios, Venizelos, Basileios, Dafni, Urania, Xepapadakis, Grigorios, Papadiamantis, John, Zobolas, Vasilios, Misitzis, John, Kalogerakos, Kyriakos, Sarantopoulou, Angeliki, Siasos, Nikolaos, Koukouras, Dimitrios, Antonopoulou, Zoh, Lazarou, Spyros, Gogas, Helen
Format:	Journal Article
Language:	English
Published:	England BioMed Central Ltd 01-01-2010 National Library of Medicine - MEDLINE Abstracts BioMed Central
Subjects:	Administration, Oral Aged Anastrozole Aromatase Inhibitors - adverse effects Aromatase Inhibitors - therapeutic use Arthralgia - chemically induced Bone Density - drug effects Bone Density Conservation Agents - administration & dosage Bone Density Conservation Agents - adverse effects Bone Density Conservation Agents - therapeutic use Breast cancer Breast Neoplasms - drug therapy Complications and side effects Dosage and administration Drug therapy Drug Therapy, Combination Dyspepsia - chemically induced Etidronic Acid - administration & dosage Etidronic Acid - adverse effects Etidronic Acid - analogs & derivatives Etidronic Acid - therapeutic use Female Humans Middle Aged Nausea - chemically induced Nitriles - adverse effects Nitriles - therapeutic use Osteoporosis Osteoporosis, Postmenopausal - chemically induced Osteoporosis, Postmenopausal - prevention & control Patient Dropouts - statistics & numerical data Prospective Studies Research article Risedronate Risedronic Acid Risk Factors Time Factors Treatment Outcome Triazoles - adverse effects Triazoles - therapeutic use Greece
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Summary:	The aim of this multicenter, phase III, prospective open label clinical trial was to investigate the effect of risedronate (R) on bone mineral density (BMD) in postmenopausal, early breast cancer (BC) patients scheduled to receive anastrozole (A). Pre-treatment BMD of 213 patients with hormone receptor-positive BC was evaluated at lumbar spine (LS) and hip (HP). Patients were categorized according to their baseline BMD T-score as being at low, moderate and high risk of osteoporosis. Low risk patients received anastrozole only (A), moderate risk were randomized to anastrozole +/- risedronate (A+/-R) administration and high risk patients received anastrozole + risedronate (A+R). Anastrozole was given at a dosage of 1 mg/day while oral risedronate was given at 35 mg/week. BMD was then assessed at 12 and 24 months. All patients received daily supplements of calcium (1000 mg/day) and vitamin D (400 IU/day). At 24 months, in the moderate risk group, treatment with A+R resulted in a significant increase in BMD at LS and HP compared to treatment with A only (5.7% v -1.5%, Wilcoxon test P = 0.006, and 1.6% v -3.9% Wilcoxon test P = 0.037, respectively), while no significant difference was found at 12 months; 24.3% of the patients moved to normal BMD region. In the high risk group, a significant increase for LS was detected both at 12 and 24 months (6.3% and 6.6%, P < 0.001) but not for HP; BMD in 14% of patients improved to the osteopenic region. In the low risk group, a significant decrease of BMD was detected at 12 months for LS and HP (-5.3% P < 0.001 and -2.4% P < 0.001, respectively,); at 24 months, a significant decrease of BMD was detected only for LS (-2.5%, P < 0.001). However, 22% of patients became osteopenic and only 4% became osteoporotic. The addition of oral risedronate in post-menopausal breast cancer patients receiving anastrozole has a favorable effect on BMD. Patients with pre-treatment osteopenic to osteoporotic status should be treated with a combination of both therapies in order to avoid bone loss induced by aromatase inhibition. Patients with normal BMD before starting treatment with anastrozole have a very low risk to develop osteoporosis.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23
ISSN:	1465-542X 1465-5411 1465-542X
DOI:	10.1186/bcr2565