Immediate versus delayed zoledronic acid for prevention of bone loss in postmenopausal women with breast cancer starting letrozole after tamoxifen-N03CC

Stephanie L. Hines; Betty Mincey; Todor Dentchev; Jeff A. Sloan; Edith A. Perez; David B. Johnson; Paul L. Schaefer; Steve Alberts; Heshan Liu; Stephen Kahanic; Miroslaw A. Mazurczak; Daniel A. Nikcevich; Charles L. Loprinzi

doi:10.1007/s10549-009-0332-2

Immediate versus delayed zoledronic acid for prevention of bone loss in postmenopausal women with breast cancer starting letrozole after tamoxifen-N03CC

Stephanie L. Hines, Betty Mincey, Todor Dentchev, Jeff A. Sloan, Edith A. Perez, David B. Johnson, Paul L. Schaefer, Steve Alberts, Heshan Liu, Stephen Kahanic, Miroslaw A. Mazurczak, Daniel A. Nikcevich, Charles L. Loprinzi

Research output: Contribution to journal › Article › peer-review

69 Scopus citations

Abstract

Postmenopausal women with breast cancer (BC) are at increased risk for bone loss. Bisphosphonates improve bone mineral density (BMD) in normal postmenopausal women. The purpose of this study was to determine if immediate treatment with zoledronic acid preserves BMD in postmenopausal women with BC starting letrozole after tamoxifen. Postmenopausal women with BC completing tamoxifen were treated with daily letrozole 2.5 mg/vitamin D 400 I.U., calcium 500 mg twice daily and were randomized to upfront or delayed zoledronic acid 4 mg every 6 months. Patients in the delayed arm were only given zoledronic acid if they developed a post-baseline BMD T score <-2.0 or had a fracture. The primary endpoint was the mean percent change in lumbar spine (LS) BMD at 1 year. About 558 women enrolled; 395 provided 1 year BMD data. The upfront arm experienced a mean change of +3.66% in LS BMD versus -1.66% for the delayed group (P < 0.001). Changes at the femoral neck/total hip were also greater for the upfront versus delayed arms (P < 0.001; P < 0.001) with differences persisting at 2 years. Patients in the delayed arm were more likely to experience a clinically meaningful 5% loss of BMD at all sites versus the upfront zoledronate group. Patients in the upfront arm were slightly more likely to report limb edema, fatigue, fever, nausea and jaw osteonecrosis(1%). Upfront zoledronic acid prevents bone loss in postmenopausal women with BC starting letrozole after tamoxifen.

Original language	English (US)
Pages (from-to)	603-609
Number of pages	7
Journal	Breast Cancer Research and Treatment
Volume	117
Issue number	3
DOIs	https://doi.org/10.1007/s10549-009-0332-2
State	Published - 2009
Externally published	Yes

Bibliographical note

Funding Information:
Acknowledgments This study was funded through the NCI with supplemental funding from Novartis. This study was conducted as a

Funding Information:
collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic and was supported in part by Public Health Service grants CA-25224, CA-37404, CA-35431, CA-35415, CA-35103, and CA-35269. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health. This work was also supported by the following United States National Institutes of Health Grant-CA 124477 (PI Charles Loprinzi MD)

Funding Information:
This study was conducted by the North Central Cancer Treatment Group (NCCTG) after approval by the National Cancer Institute (NCI) and the local Institutional Review Boards from participating sites. Informed written consent was obtained from all participants prior to enrollment. The study was primarily funded by the NCI, with supplemental funding provided by Novartis, who had no involvement in the conduct of the study.

Keywords

Aromatase inhibitor
Bone loss
Breast cancer
Zoledronic acid

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1007/s10549-009-0332-2

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Hines, S. L., Mincey, B., Dentchev, T., Sloan, J. A., Perez, E. A., Johnson, D. B., Schaefer, P. L., Alberts, S., Liu, H., Kahanic, S., Mazurczak, M. A., Nikcevich, D. A., & Loprinzi, C. L. (2009). Immediate versus delayed zoledronic acid for prevention of bone loss in postmenopausal women with breast cancer starting letrozole after tamoxifen-N03CC. Breast Cancer Research and Treatment, 117(3), 603-609. https://doi.org/10.1007/s10549-009-0332-2

Hines, SL, Mincey, B, Dentchev, T, Sloan, JA, Perez, EA, Johnson, DB, Schaefer, PL, Alberts, S, Liu, H, Kahanic, S, Mazurczak, MA, Nikcevich, DA & Loprinzi, CL 2009, 'Immediate versus delayed zoledronic acid for prevention of bone loss in postmenopausal women with breast cancer starting letrozole after tamoxifen-N03CC', Breast Cancer Research and Treatment, vol. 117, no. 3, pp. 603-609. https://doi.org/10.1007/s10549-009-0332-2

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title = "Immediate versus delayed zoledronic acid for prevention of bone loss in postmenopausal women with breast cancer starting letrozole after tamoxifen-N03CC",

abstract = "Postmenopausal women with breast cancer (BC) are at increased risk for bone loss. Bisphosphonates improve bone mineral density (BMD) in normal postmenopausal women. The purpose of this study was to determine if immediate treatment with zoledronic acid preserves BMD in postmenopausal women with BC starting letrozole after tamoxifen. Postmenopausal women with BC completing tamoxifen were treated with daily letrozole 2.5 mg/vitamin D 400 I.U., calcium 500 mg twice daily and were randomized to upfront or delayed zoledronic acid 4 mg every 6 months. Patients in the delayed arm were only given zoledronic acid if they developed a post-baseline BMD T score <-2.0 or had a fracture. The primary endpoint was the mean percent change in lumbar spine (LS) BMD at 1 year. About 558 women enrolled; 395 provided 1 year BMD data. The upfront arm experienced a mean change of +3.66% in LS BMD versus -1.66% for the delayed group (P < 0.001). Changes at the femoral neck/total hip were also greater for the upfront versus delayed arms (P < 0.001; P < 0.001) with differences persisting at 2 years. Patients in the delayed arm were more likely to experience a clinically meaningful 5% loss of BMD at all sites versus the upfront zoledronate group. Patients in the upfront arm were slightly more likely to report limb edema, fatigue, fever, nausea and jaw osteonecrosis(1%). Upfront zoledronic acid prevents bone loss in postmenopausal women with BC starting letrozole after tamoxifen.",

keywords = "Aromatase inhibitor, Bone loss, Breast cancer, Zoledronic acid",

author = "Hines, {Stephanie L.} and Betty Mincey and Todor Dentchev and Sloan, {Jeff A.} and Perez, {Edith A.} and Johnson, {David B.} and Schaefer, {Paul L.} and Steve Alberts and Heshan Liu and Stephen Kahanic and Mazurczak, {Miroslaw A.} and Nikcevich, {Daniel A.} and Loprinzi, {Charles L.}",

note = "Funding Information: Acknowledgments This study was funded through the NCI with supplemental funding from Novartis. This study was conducted as a Funding Information: collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic and was supported in part by Public Health Service grants CA-25224, CA-37404, CA-35431, CA-35415, CA-35103, and CA-35269. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health. This work was also supported by the following United States National Institutes of Health Grant-CA 124477 (PI Charles Loprinzi MD) Funding Information: This study was conducted by the North Central Cancer Treatment Group (NCCTG) after approval by the National Cancer Institute (NCI) and the local Institutional Review Boards from participating sites. Informed written consent was obtained from all participants prior to enrollment. The study was primarily funded by the NCI, with supplemental funding provided by Novartis, who had no involvement in the conduct of the study.",

year = "2009",

doi = "10.1007/s10549-009-0332-2",

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AU - Sloan, Jeff A.

AU - Perez, Edith A.

AU - Johnson, David B.

AU - Schaefer, Paul L.

AU - Alberts, Steve

AU - Liu, Heshan

AU - Kahanic, Stephen

AU - Mazurczak, Miroslaw A.

AU - Nikcevich, Daniel A.

AU - Loprinzi, Charles L.

N1 - Funding Information: Acknowledgments This study was funded through the NCI with supplemental funding from Novartis. This study was conducted as a Funding Information: collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic and was supported in part by Public Health Service grants CA-25224, CA-37404, CA-35431, CA-35415, CA-35103, and CA-35269. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health. This work was also supported by the following United States National Institutes of Health Grant-CA 124477 (PI Charles Loprinzi MD) Funding Information: This study was conducted by the North Central Cancer Treatment Group (NCCTG) after approval by the National Cancer Institute (NCI) and the local Institutional Review Boards from participating sites. Informed written consent was obtained from all participants prior to enrollment. The study was primarily funded by the NCI, with supplemental funding provided by Novartis, who had no involvement in the conduct of the study.

PY - 2009

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AB - Postmenopausal women with breast cancer (BC) are at increased risk for bone loss. Bisphosphonates improve bone mineral density (BMD) in normal postmenopausal women. The purpose of this study was to determine if immediate treatment with zoledronic acid preserves BMD in postmenopausal women with BC starting letrozole after tamoxifen. Postmenopausal women with BC completing tamoxifen were treated with daily letrozole 2.5 mg/vitamin D 400 I.U., calcium 500 mg twice daily and were randomized to upfront or delayed zoledronic acid 4 mg every 6 months. Patients in the delayed arm were only given zoledronic acid if they developed a post-baseline BMD T score <-2.0 or had a fracture. The primary endpoint was the mean percent change in lumbar spine (LS) BMD at 1 year. About 558 women enrolled; 395 provided 1 year BMD data. The upfront arm experienced a mean change of +3.66% in LS BMD versus -1.66% for the delayed group (P < 0.001). Changes at the femoral neck/total hip were also greater for the upfront versus delayed arms (P < 0.001; P < 0.001) with differences persisting at 2 years. Patients in the delayed arm were more likely to experience a clinically meaningful 5% loss of BMD at all sites versus the upfront zoledronate group. Patients in the upfront arm were slightly more likely to report limb edema, fatigue, fever, nausea and jaw osteonecrosis(1%). Upfront zoledronic acid prevents bone loss in postmenopausal women with BC starting letrozole after tamoxifen.

KW - Aromatase inhibitor

KW - Bone loss

KW - Breast cancer

KW - Zoledronic acid

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Immediate versus delayed zoledronic acid for prevention of bone loss in postmenopausal women with breast cancer starting letrozole after tamoxifen-N03CC

Abstract

Bibliographical note

Keywords

UN SDGs

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