Searchable abstracts of presentations at key conferences on calcified tissues
Bone Abstracts (2013) 1 PP131 | DOI: 10.1530/boneabs.1.PP131

ECTS2013 Poster Presentations Calciotropic and phosphotropic hormones and mineral metabolism (33 abstracts)

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

Peyman Hadji 1 , Anette Kauka 1 , Thomas Bauer 1 , May Ziller 1 , Katrin Birkholz 2 , Monika Baier 2 , Mathias Muth 2 & Peter Kann 3


1Department of Gynecology, Endocrinology and Oncology, Philipps-University of Marburg, Universitatsklinikum Giessen und Marburg, Marburg, Germany; 2Novartis Pharma GmbH, Nuernberg, Germany; 3Department of Endocrinology and Diabetes, Philipps-University of Marburg, Universitatsklinikum Giessen und Marburg, Marburg, Germany.


Introduction: Loss in bone mineral density may occur soon after initiation of adjuvant therapy for hormone-receptor-positive (HR+), breast cancer (BC) and correlates with changes in hormone levels. Adding zoledronic acid (ZOL) to adjuvant treatment for BC can preserve/improve bone mineral density and delay disease recurrence; however, effects of ZOL on endocrine hormone levels are currently unclear.

Methods: Probone II assessed the course of endocrine hormones (estradiol; parathyroid (PTH), FSH, anti-Müllerian (AMH); inhibins A/B; sex-hormone-binding globulin; and total testosterone) in premenopausal women with HR+BC during 24 months of neoadjuvant or adjuvant treatment with chemotherapy (CT)/endocrine therapy (ET), and ZOL (4 μg q 3 months) or placebo. Safety was continuously monitored.

Results: Patients (n=70; mean age=43 years (range, 23–51 years)) had predominant diagnosis of T1/N0–1/M0 BC. Adjuvant CT was primarily standard anthracycline–cyclophosphamide followed by taxane; adjuvant ET involved GnRH analogue (84.3%) and tamoxifen (94.3%). Estradiol levels reached nadir after 3 months in placebo and 9 months in ZOL groups. In both groups, FSH levels increased by month 3 and returned to near baseline by treatment end; in contrast, inhibins A/B decreased by month 6 and remained low throughout. Levels of AMH decreased by 57 and 71% by month 6 in placebo and ZOL groups, respectively, with continued decrease on-study in ZOL group (vs remaining constant with placebo). Testosterone and PTH levels tended to be slightly higher in ZOL-treated patients vs placebo. The most frequent treatment-emergent adverse events were consistent with known profiles of ZOL and adjuvant therapy.

Conclusions: Hormonal effects of 2 years of adjuvant treatment in this study were consistent with earlier reports of CT/ET. Adding ZOL (4 μg q 3 months) did not affect changes in hormone levels that accompany CT/ET in HR+BC, suggesting that adjuvant benefits observed with ZOL in some patient populations are mediated through nonhormonal mechanisms.

Volume 1

European Calcified Tissue Society Congress 2013

Lisbon, Portugal
18 May 2013 - 22 May 2013

European Calcified Tissue Society 

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