Effects of zoledronic acid on hormone levels in premenopausal women with breast cancer receiving neoadjuvant or adjuvant chemotherapy and endocrine therapy: Probone II Study

2013 ◽  
Author(s):  
Peyman Hadji ◽  
Anette Kauka ◽  
Thomas Bauer ◽  
May Ziller ◽  
Katrin Birkholz ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Zoledronic Acid ◽  
Adjuvant Chemotherapy ◽  
Endocrine Therapy ◽  
Premenopausal Women ◽  
Hormone Levels

Zoledronic Acid Prevents Cancer Treatment–Induced Bone Loss in Premenopausal Women Receiving Adjuvant Endocrine Therapy for Hormone-Responsive Breast Cancer: A Report From the Austrian Breast and Colorectal Cancer Study Group

2007 ◽  
Vol 25 (7) ◽  
pp. 820-828 ◽  
Author(s):  
Michael F.X. Gnant ◽  
Brigitte Mlineritsch ◽  
Gero Luschin-Ebengreuth ◽  
Stephan Grampp ◽  
Helmut Kaessmann ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Zoledronic Acid ◽  
Bone Loss ◽  
Endocrine Therapy ◽  
Premenopausal Women ◽  
Adjuvant Endocrine Therapy ◽  
Phase Iii ◽  
Endocrine Treatment ◽  
Mineral Density ◽  
T Score

Purpose Adjuvant therapy for breast cancer can be associated with decreased bone mineral density (BMD) that may lead to skeletal morbidity. This study examined whether zoledronic acid can prevent bone loss associated with adjuvant endocrine therapy in premenopausal patients. Patients and Methods This study is a randomized, open-label, phase III, four-arm trial comparing tamoxifen (20 mg/d orally) and goserelin (3.6 mg every 28 days subcutaneously) ± zoledronic acid (4 mg intravenously every 6 months) versus anastrozole (1 mg/d orally) and goserelin ± zoledronic acid for 3 years in premenopausal women with hormone-responsive breast cancer. In a BMD subprotocol at three trial centers, patients underwent serial BMD measurements at 0, 6, 12, 24, and 36 months. Results Four hundred one patients were included in the BMD subprotocol. Endocrine treatment without zoledronic acid led to significant (P < .001) overall bone loss after 3 years of treatment (BMD, −14.4% after 36 months; mean T score reduction, −1.4). Overall bone loss was significantly more severe in patients receiving anastrozole/goserelin (BMD, −17.3%; mean T score reduction, −2.6) compared with patients receiving tamoxifen/goserelin (BMD, −11.6%; mean T score reduction, −1.1). In contrast, BMD remained stable in zoledronic acid–treated patients (P < .0001 compared with endocrine therapy alone). No interactions with age or other risk factors were noted. Conclusion Endocrine therapy caused significant bone loss that increased with treatment duration in premenopausal women with breast cancer. Zoledronic acid 4 mg every 6 months effectively inhibited bone loss. Regular BMD measurements and initiation of concomitant bisphosphonate therapy on evidence of bone loss should be considered for patients undergoing endocrine therapy.

Cost-Effectiveness of Zoledronic Acid Plus Endocrine Therapy in Premenopausal Women With Hormone-Responsive Early Breast Cancer

2010 ◽  
Vol 10 (4) ◽  
pp. 267-274 ◽  
Author(s):  
Thomas E. Delea ◽  
Charu Taneja ◽  
Oleg Sofrygin ◽  
Satyin Kaura ◽  
Michael Gnant
Keyword(s):  
Breast Cancer ◽  
Cost Effectiveness ◽  
Zoledronic Acid ◽  
Endocrine Therapy ◽  
Early Breast Cancer ◽  
Premenopausal Women

scholarly journals Zoledronic Acid Prevents Bone Loss in Premenopausal Women Undergoing Adjuvant Chemotherapy for Early-Stage Breast Cancer

2008 ◽  
Vol 26 (29) ◽  
pp. 4739-4745 ◽  
Author(s):  
Dawn L. Hershman ◽  
Donald J. McMahon ◽  
Katherine D. Crew ◽  
Serge Cremers ◽  
Dinaz Irani ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Zoledronic Acid ◽  
Adjuvant Chemotherapy ◽  
Bone Loss ◽  
Repeated Measures ◽  
Early Stage ◽  
Premenopausal Women ◽  
Phase Iii ◽  
Mineral Density ◽  
Percent Change

Purpose Adjuvant chemotherapy for breast cancer (BC) may be associated with increased rates of bone loss and decreased bone mineral density (BMD) and may lead to premature osteoporosis and increased fracture risk. We examined whether zoledronic acid (ZA) prevents bone loss in premenopausal women receiving chemotherapy for early-stage BC. Patients and Methods This study is a randomized, double-blind, multicenter, phase III trial comparing ZA (4 mg intravenously every 3 months) versus placebo for 1 year. Premenopausal women underwent serial BMD measurements before initiating chemotherapy and at 6 and 12 months. The primary outcome was percent change in lumbar spine (LS) BMD at 6 months. Secondary outcomes were percent change at any BMD site and markers of bone turnover at 12 months. Linear mixed model analysis for repeated measures was performed. Results Of 101 women who were randomly assigned and completed baseline evaluation, 96 completed the 6-month evaluation, and 85 completed the 12-month evaluation. Baseline characteristics were comparable between the groups. Mean age was 42 years. Placebo was associated with significant decline in LS BMD at both 6 (2.4%) and 12 (4.1%) months. Similarly, total hip BMD declined by 0.8% at 6 months and 2.6% at 12 months. In contrast, BMD remained stable in ZA patients (P < .0001 compared with placebo). Conclusion Premenopausal women receiving chemotherapy for BC sustained significant bone loss at the LS and hip, whereas BMD remained stable in women who received ZA. Administration of ZA during the first year of chemotherapy is an effective and well-tolerated strategy for preventing bone loss.

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