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

2009 ◽  
Vol 20 (4) ◽  
pp. 372-373
Author(s):  
C.L. Shapiro
Keyword(s):  
Breast Cancer ◽  
Zoledronic Acid ◽  
Adjuvant Chemotherapy ◽  
Bone Loss ◽  
Early Stage ◽  
Premenopausal Women ◽  
Early Stage Breast Cancer

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.

Adjuvant zoledronic acid (ZOL) in postmenopausal women with breast cancer and those rendered postmenopausal: Results of a meta-analysis.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 513-513 ◽  
Author(s):  
Walter Gregory ◽  
Helen Marshall ◽  
Richard Bell ◽  
David A. Cameron ◽  
Robert Edward Coleman
Keyword(s):  
Breast Cancer ◽  
Zoledronic Acid ◽  
Postmenopausal Women ◽  
Risk Reduction ◽  
Early Stage ◽  
Meta Analysis ◽  
Menopausal Status ◽  
Premenopausal Women ◽  
Early Stage Breast Cancer ◽  
Sensitivity Analyses

513 Background: A number of groups have now reported results of randomised trials of adjuvant zoledronic acid (ZOL) for women with early stage breast cancer. Following an interaction effect observed in the AZURE trial, where postmenopausal women appeared to benefit from ZOL, we performed a meta-analysis, from both publications and presented data, of the most recent results from these trials. We also looked at recently reported large studies of clodronate and ibandronate in older or postmenopausal women to further examine this hypothesis. Methods: DFS data from 8735 women in 7 trials (AZURE, ABCSG-12, ZO-FAST, Z-FAST, EZO-FAST, NSABP-B34, GAIN) that included a randomization to ZOL vs. control or clodronate/ibandronate vs. control were examined. Median follow-up was 5 years. 14% of women experienced a DFS event. The ABCSG-12 study was included since, although it included only premenopausal women, they were all treated with goserelin, effectively rendering them postmenopausal, prior to and during treatment with ZOL. We analysed the subgroup of women aged ≥50 in the NSABP-B34 study in the absence of information on menopausal status, and included only postmenopausal women from the AZURE and GAIN trials. Sensitivity analyses confirmed that exclusion of some older, small, clodronate studies that lacked DFS data, or failed to report by age or menopausal status would be unlikely to alter these findings. Results: For the 5 ZOL studies alone, there was a very substantial and highly significant DFS benefit for ZOL, 2P=.0006, with a hazard ratio of 0.76, and therefore a DFS risk reduction of 24% (95% CI 11%-35%). The results were, in the main, extremely consistent, with the exception of the very small E-ZO-FAST study, which had only 30 events. The risk reduction lessened to 18% (95% CI 8%-26%) when adding in the clodronate and ibandronate studies, but the result remained highly significant (2P=.00075). Conclusions: These meta-analysis results, including more than 8000 women in a range of studies, now provide strong evidence that ZOL is an effective adjuvant treatment for postmenopausal women with early stage breast cancer, and that the treatment benefits are substantial.

Association of osteprotegerin, bone turnover, and bone loss after adjuvant chemotherapy in early-stage breast cancer.

2013 ◽  
Vol 31 (26_suppl) ◽  
pp. 134-134
Author(s):  
Drew Randall Oostra ◽  
Maryam B. Lustberg ◽  
Xueliang Jeff Pan ◽  
Charles L. Shapiro
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Bone Resorption ◽  
Bone Loss ◽  
Early Stage ◽  
Stage I ◽  
Early Stage Breast Cancer ◽  
Breast Cancers ◽  
Mineral Density ◽  
Compensatory Response

134 Background: Chemotherapy induced ovarian failure (CIOF) results in rapid bone loss. RANK-RANK ligand (RANK-L) signaling is important in regulating osteoclast development and is essential in maintaining the balance between bone resorption and formation. Osteoprotegerin (OPG) is involved in RANK-RANKL signaling by acting as a decoy receptor for RANK and thus interrupting osteoclast activation and subsequent bone resorption. The objective of this study was to examine the relationship between OPG and bone health in women with early-stage breast cancer who develop CIOF. Methods: Premenopausal women with stage I and II breast cancers receiving adjuvant chemotherapy were evaluated, within 4 weeks of starting chemotherapy (baseline), at 6 months and at 12 months. They were evaluated with bone mineral density (BMD) at lumbar spine (LS), BMD at femoral neck (FN), follicle stimulating hormone (FSH), ionized calcium (iCa), osteocalcin (OC) and osteoprotegerin (OPG) measurements. CIOF was defined as negative pregnancy test, 3 or more months of amenorrhea, and an FSH >30 MIU/mL at the 12 month time point. Results: Forty women with stage I and II breast cancer receiving adjuvant were included in this analysis. Thirty-one (77.5%) were identified as having CIOF. In the CIOF group, there was statistically significant decreases in BMD (at the LS and FN) at both 6 months and 12 months (all P's <0.001). The LS BMD decreased from 0.993 (0.935-1.123), to 0.976 (0.869-1.100) to 0.937 (0.834-1.062), at 6 and 12 months respectively (median and inter-quartile range). OPG was significantly increased at 6 months (median increase 0.30, P=0.015), and then went down at 12 months, but was still higher than baseline (although not statistically significant, median difference 0.2, p=0.70). Significant increases in OC were also noted at 6 and 12 months (both P<0.001). Conclusions: In the CIOF group, OPG increases in the first 6 months in CIOF and at 12 months was slightly decreased but still remained elevated over baseline. This is likely due to a compensatory response to rapid bone loss. This compensatory response has been reported in other diseases, but not in CIOF.

Zoledronic Acid Inhibits Adjuvant Letrozole–Induced Bone Loss in Postmenopausal Women With Early Breast Cancer

2007 ◽  
Vol 25 (7) ◽  
pp. 829-836 ◽  
Author(s):  
Adam Brufsky ◽  
W. Graydon Harker ◽  
J. Thaddeus Beck ◽  
Robert Carroll ◽  
Elizabeth Tan-Chiu ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Zoledronic Acid ◽  
Bone Loss ◽  
Postmenopausal Women ◽  
Early Stage ◽  
Early Stage Breast Cancer ◽  
Mineral Density ◽  
Acid Therapy ◽  
End Point ◽  
Delayed Group

Purpose Treatment with aromatase inhibitors decreases bone mineral density (BMD) and may increase the risk of fractures in postmenopausal women with early-stage breast cancer. The addition of zoledronic acid to adjuvant letrozole therapy may protect against bone loss. Patients and Methods Patients receiving adjuvant letrozole were randomly assigned to receive either upfront or delayed-start zoledronic acid (4 mg intravenously every 6 months). The delayed group received zoledronic acid when lumbar spine (LS) or total hip (TH) T score decreased to less than −2.0 or when a nontraumatic fracture occurred. The primary end point of this study was to compare the change in LS BMD at month 12 between the groups. Secondary end points included change in TH BMD and changes in serum bone turnover markers at month 12. Results The upfront and delayed groups each included 301 patients. At month 12, LS BMD was 4.4% higher in the upfront group than in the delayed group (95% CI, 3.7% to 5.0%; P < .0001), and TH BMD was 3.3% higher (95% CI, 2.8% to 3.8%; P < .0001). In the upfront group, mean serum N-telopeptide and bone-specific alkaline phosphatase concentrations decreased by 15.1% (P < .0001) and 8.8% (P = .0006), respectively, at month 12, whereas concentrations increased significantly in the delayed group by 19.9% (P = .013) and 24.3% (P < .0001), respectively. Conclusion With 1 year of follow-up, results of the primary end point of the Zometa-Femara Adjuvant Synergy Trial (Z-FAST) indicate that upfront zoledronic acid therapy prevents bone loss in the LS in postmenopausal women receiving adjuvant letrozole for early-stage breast cancer.

scholarly journals Association of osteoprotegerin and bone loss after adjuvant chemotherapy in early-stage breast cancer

2015 ◽  
Vol 402 ◽  
pp. 51-56 ◽  
Author(s):  
Drew R. Oostra ◽  
Maryam B. Lustberg ◽  
Raquel E. Reinbolt ◽  
Xueliang Pan ◽  
Robert Wesolowski ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Bone Loss ◽  
Early Stage ◽  
Early Stage Breast Cancer
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