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Practice Guideline
. 2025 Oct;111(5):366-378.
doi: 10.1177/03008916251367339. Epub 2025 Sep 15.

The use of bone-modifying agents in early breast cancer: AIOM Guidelines update and perspectives

Alberto Zambelli  1   2 , Riccardo Gerosa  3   4 , Michela Cinquini  5 , Massimo Di Maio  6 , Federica Miglietta  7   8 , Luca Arecco  9   10 , Laura Biganzoli  11 , Daniela Bernardi  3   4 , Laura Cortesi  12   13 , Lucia Del Mastro  10   14 , Maria V Dieci  7   8 , Jennifer Foglietta  15 , Lucio Fortunato  16 , Pierfrancesco Franco  17   18 , Paola Mantellini  19 , Caterina Marchiò  20   21 , Bruno Meduri  22 , Giovanni Micallo  23 , Antonino Musolino  24 , Andrea Salvetti  25 , Daniele Santini  26 , Gaetano Lanzetta  27 , Deborah Cosentini  28 , Francesco Bertoldo  29   30 , Roberto Luigi Cazzato  31 , Francesco Cellini  32   33 , Vincenzo Denaro  34   35 , Alberto Di Martino  36   37 , Vittorio Fusco  38 , Carlo Greco  39   40 , Toni Ibrahim  41 , Giulio Maccauro  42   43 , Giulia DeFeo  44 , Stefano Severi  45 , Stefania Gori  46
Affiliations
Practice Guideline

The use of bone-modifying agents in early breast cancer: AIOM Guidelines update and perspectives

Alberto Zambelli et al. Tumori. 2025 Oct.

Abstract

Breast cancer (BC) is the leading cause of cancer-related mortality among women, with early BC (EBC) comprising most cases. Advancements in neo(adjuvant) therapies have significantly improved outcomes, although they are often associated with cancer treatment-induced bone loss, which increases the risk of fractures and negatively impacts quality of life. Bone-modifying agents (BMAs), such as bisphosphonates and denosumab can mitigate this adverse effect. By reviewing and summarizing the most recent evidence published on BMAs use in EBC, an expert Italian Panel, composed of the authors of the Italian Association of Medical Oncology (AIOM) guidelines, offers an extended clinical interpretation and updated overview of key questions and recommendation, including the optimal timing of BMAs initiation, appropriate treatment duration, and the most effective agents for fracture risk reduction. Additionally, a critical and previously unaddressed topic is also discussed: BMAs impact on survival outcomes in EBC scenario. This paper offers practical insights into bone health management for EBC patients, explores the potential survival benefits offered by BMAs, and highlights differences among international guidelines regarding their recommended use.

Keywords: Bone-modifying agents (BMAs); Cancer treatment-induced bone loss (CTIBL); Early breast cancer (EBC); Long-term outcomes; bisphosphonates (BPs); denosumab.

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Conflict of interest statement

Declaration of conflicting interestsThe authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: L. Arecco: travel grant from AstraZeneca; research grant to the institution from Gilead. F. Miglietta: personal fees from Roche, Novartis, Pfizer/Seagen, MSD, Astrazeneca, Daiichi Sankyo, Menarini Stemline, Gilead. L. Del Mastro: Grants or contracts from Eli lilly; Novartis; Roche; Daiichi Sankyo; Seagen; Astrazeneca; Gilead; Pierre Fabre; Pfizer. Consulting fees: Eli lilly; Gilead; Daiichi Sankyio; Menarini Stemline; Novartis; Olema; Astrazeneca; MSD; Pfizer. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events Roche – Novartis - Pfizer – Eli lilly – Astrazeneca – MSD – Seagen – Gilead – Pierre Fabre – Eisai – Exact sciences – Ipsen – GSK – Agendia - Menarini Stemline. Support for attending meetings and/or travel: Roche – Daiichi Sankyo – Astrazeneca – Gilead – Menarini Stemline. Participation on a Data Safety Monitoring Board or Advisory Board Novartis – Roche – Eli Lilly – Pfizer – Daiichi Sakyo – Exact sciences – Gilead – Pierre Fabre – Eisai – Astrazeneca -Agendia – GSK -Seagen – MSD – Olema. T. Ibrahim (last 2 years): Fee for consultant (Pharmamar and Ipsen) and for speaker’s bureau (Istituto Gentili). L. Biganzoli: Personal financial interests (Honoraria, consultancy or advisory role): Amgen, Institutional financial interests: Novartis. M. Di Maio: Honoraria for consultancy or participation to advisory boards from AstraZeneca, Boehringer Ingelheim, Janssen, Merck Sharp & Dohme (MSD), Novartis, Pfizer, Roche, GlaxoSmithKline, Amgen, Merck, Takeda, Viatris, Ipsen, Astellas; institutional funding for work in clinical trials/contracted research from Beigene, Exelixis, MSD, Pfizer and Roche; AIOM president elect. J. Foglietta: personal fees from Pfizer/Seagen, Astrazeneca, Daiichi Sankyo, Menarini Stemline. L. Cortesi: Grants:Astra Zeneca, MSD, Pfizer; Consulting fees: Astra Zeneca, MSD, Pfizer, Novartis, Gilead, Roche, Daichii-Sankyo; Advisory Board:Astrazeneca, MSD, Daichii-Sankyo. L. Fortunato: Advisory Board MSD.All other authors: no recent (last 2 years) declarations related with this paper.

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