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, Steven Robert Alberts, Heshan Liu, Stephen Kahanic, Miroslaw A. Mazurczak, Daniel A. Nikcevich, Charles Lawrence Loprinzi

Research output: Contribution to journalArticle

53 Citations (Scopus)

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 languageEnglish (US)
Pages (from-to)603-609
Number of pages7
JournalBreast Cancer Research and Treatment
Volume117
Issue number3
DOIs
StatePublished - 2009

Fingerprint

letrozole
zoledronic acid
Postmenopausal Osteoporosis
Tamoxifen
Bone Density
Breast Neoplasms
Arm
Spine
Osteonecrosis
Femur Neck
Diphosphonates
Jaw
Vitamin D
Nausea
Fatigue
Hip
Edema

Keywords

  • Aromatase inhibitor
  • Bone loss
  • Breast cancer
  • Zoledronic acid

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Immediate versus delayed zoledronic acid for prevention of bone loss in postmenopausal women with breast cancer starting letrozole after tamoxifen-N03CC. / Hines, Stephanie L.; Mincey, Betty; Dentchev, Todor; Sloan, Jeff A; Perez, Edith A.; Johnson, David B.; Schaefer, Paul L.; Alberts, Steven Robert; Liu, Heshan; Kahanic, Stephen; Mazurczak, Miroslaw A.; Nikcevich, Daniel A.; Loprinzi, Charles Lawrence.

In: Breast Cancer Research and Treatment, Vol. 117, No. 3, 2009, p. 603-609.

Research output: Contribution to journalArticle

Hines, Stephanie L. ; Mincey, Betty ; Dentchev, Todor ; Sloan, Jeff A ; Perez, Edith A. ; Johnson, David B. ; Schaefer, Paul L. ; Alberts, Steven Robert ; Liu, Heshan ; Kahanic, Stephen ; Mazurczak, Miroslaw A. ; Nikcevich, Daniel A. ; Loprinzi, Charles Lawrence. / Immediate versus delayed zoledronic acid for prevention of bone loss in postmenopausal women with breast cancer starting letrozole after tamoxifen-N03CC. In: Breast Cancer Research and Treatment. 2009 ; Vol. 117, No. 3. pp. 603-609.
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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.",
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