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Zoledronic acid preserves bone mineral density in premenopausal women who develop ovarian failure due to adjuvant chemotherapy: final results from CALGB trial 79809.

Publication ,  Journal Article
Shapiro, CL; Halabi, S; Hars, V; Archer, L; Weckstein, D; Kirshner, J; Sikov, W; Winer, E; Burstein, HJ; Hudis, C; Isaacs, C; Schilsky, R; Paskett, E
Published in: Eur J Cancer
March 2011

BACKGROUND: Chemotherapy-induced ovarian failure (CIOF) is a frequent side-effect of adjuvant chemotherapy that results in rapid bone loss. We hypothesised that zoledronic acid (ZA), a third-generation amino bisphosphonate, would prevent bone loss in premenopausal women who developed CIOF. METHODS: Women (439) were randomised to intravenous (i.v.) ZA 4 mg every 3 months for 2 years starting within 1-3 months after randomization (arm A) or 1 year after randomization (arm B, controls). CIOF was prospectively defined as ≥ 3 months of amenorrhoea, follicle-stimulating hormone (FSH) ≥ 30 MIU/ml and non-pregnant at 1 year. The primary end-point was the percentage change in bone mineral density (BMD) in the lumbar spine (LS) from baseline to 12 months in the ZA and in control groups in women who developed CIOF; the secondary end-point was BMD in LS at 3 years in all randomised women. FINDINGS: One hundred and fifty (56%) met the definition of CIOF at 1 year. Overall, grade 3 toxicities of ZA were fatigue (1%) arthralgias (21%) and pain (84%). The median percent change (interquartile range, IQR) at 1 year was +1.2% (-0.5% to +2.8%) and -6.7% (-9.7% to -2.9%) p<0.001 and at 3 years was +1.0% (-1.6% to +5.2%) and -0.5% (-3.7% to +3.2%) p=0.019 in arms A and B, respectively. INTERPRETATION: ZA every 3 months is well tolerated and prevents rapid bone loss in premenopausal women that develop CIOF. Giving ZA with rather than 1 year after the start of adjuvant chemotherapy is the preferred sequence to prevent bone loss.

Duke Scholars

Published In

Eur J Cancer

DOI

EISSN

1879-0852

Publication Date

March 2011

Volume

47

Issue

5

Start / End Page

683 / 689

Location

England

Related Subject Headings

  • Zoledronic Acid
  • Prospective Studies
  • Primary Ovarian Insufficiency
  • Premenopause
  • Pain
  • Oncology & Carcinogenesis
  • Middle Aged
  • Infusions, Intravenous
  • Imidazoles
  • Humans
 

Citation

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MLA
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Shapiro, C. L., Halabi, S., Hars, V., Archer, L., Weckstein, D., Kirshner, J., … Paskett, E. (2011). Zoledronic acid preserves bone mineral density in premenopausal women who develop ovarian failure due to adjuvant chemotherapy: final results from CALGB trial 79809. Eur J Cancer, 47(5), 683–689. https://doi.org/10.1016/j.ejca.2010.11.024
Shapiro, C. L., S. Halabi, V. Hars, L. Archer, D. Weckstein, J. Kirshner, W. Sikov, et al. “Zoledronic acid preserves bone mineral density in premenopausal women who develop ovarian failure due to adjuvant chemotherapy: final results from CALGB trial 79809.Eur J Cancer 47, no. 5 (March 2011): 683–89. https://doi.org/10.1016/j.ejca.2010.11.024.
Shapiro CL, Halabi S, Hars V, Archer L, Weckstein D, Kirshner J, et al. Zoledronic acid preserves bone mineral density in premenopausal women who develop ovarian failure due to adjuvant chemotherapy: final results from CALGB trial 79809. Eur J Cancer. 2011 Mar;47(5):683–9.
Shapiro, C. L., et al. “Zoledronic acid preserves bone mineral density in premenopausal women who develop ovarian failure due to adjuvant chemotherapy: final results from CALGB trial 79809.Eur J Cancer, vol. 47, no. 5, Mar. 2011, pp. 683–89. Pubmed, doi:10.1016/j.ejca.2010.11.024.
Shapiro CL, Halabi S, Hars V, Archer L, Weckstein D, Kirshner J, Sikov W, Winer E, Burstein HJ, Hudis C, Isaacs C, Schilsky R, Paskett E. Zoledronic acid preserves bone mineral density in premenopausal women who develop ovarian failure due to adjuvant chemotherapy: final results from CALGB trial 79809. Eur J Cancer. 2011 Mar;47(5):683–689.
Journal cover image

Published In

Eur J Cancer

DOI

EISSN

1879-0852

Publication Date

March 2011

Volume

47

Issue

5

Start / End Page

683 / 689

Location

England

Related Subject Headings

  • Zoledronic Acid
  • Prospective Studies
  • Primary Ovarian Insufficiency
  • Premenopause
  • Pain
  • Oncology & Carcinogenesis
  • Middle Aged
  • Infusions, Intravenous
  • Imidazoles
  • Humans