Determinants of vertebral fractures and effectiveness of anti-resorptive drmgs in pre-menopausal women with early breast cancer under hormone deprivation therapies: A multicenter real-world study

Giacomo Cristofolini; Rebecca Pedersini; Andrea Palermo; Walter Vena; Barbara Presciuttini; Maria Francesca Birtolo; Gaia Tabacco; Anda Mihaela Naciu; Stella Pigni; Marta Lagana; Federica Mazzoleni; Deborah Cosentini; Antea Ciafardini; Mauro Pagani; Davide Farina; Luca Balzarini; Alberto Zambelli; Rosalba Torrisi; Luisella Cianferotti; Nicola Napoli; Antonio Carlo Bossi; Alfredo Berruti; Andrea Lania; Gherardo Mazziotti

doi:10.1530/endoabs.99.RC10.5

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Endocrine Abstracts (2024) 99 RC10.5 | DOI: 10.1530/endoabs.99.RC10.5

ECE2024 Rapid Communications Rapid Communications 10: Calcium and Bone | Part II (5 abstracts)

Determinants of vertebral fractures and effectiveness of anti-resorptive drmgs in pre-menopausal women with early breast cancer under hormone deprivation therapies: A multicenter real-world study

Giacomo Cristofolini ^1,2 , Rebecca Pedersini ³ , Andrea Palermo ⁴ , Walter Vena ^1,5 , Barbara Presciuttini ⁶ , Maria Francesca Birtolo ^1,2 , Gaia Tabacco ⁴ , Anda Mihaela Naciu ⁴ , Stella Pigni ^1,2 , Marta Lagana ³ , Federica Mazzoleni ⁵ , Deborah Cosentini ³ , Antea Ciafardini ^1,2 , Mauro Pagani ⁶ , Davide Farina ⁷ , Luca Balzarini ⁸ , Alberto Zambelli ^1,9 , Rosalba Torrisi ⁹ , Luisella Cianferotti ¹⁰ , Nicola Napoli ^4,11,12 , Antonio Carlo Bossi ⁵ , Alfredo Berruti ³ , Andrea Lania ^1,2 & Gherardo Mazziotti ^1,2

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Author affiliations

¹Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Italy; ²IRCCS Humanitas Research Hospital, Endocrinology, Diabetology and Medical Andrology Unit, Rozzano, Italy; ³University of Brescia, ASST Spedali Civili, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, Medical Oncology, Brescia, Italy; ⁴Unit of Metabolic Bone and Thyroid Diseases, Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy; ⁵Humanitas Gavazzeni, Diabetology and Endocrinology, Bergamo, Italy; ⁶ASST Carlo Poma, Endocrinology Unit, Department of Medicine, Mantua, Italy; ⁷University of Brescia, ASST Spedali Civili, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, Radiology, Brescia, Italy; ⁸IRCCS Humanitas Research Hospital, Department of Radiology, Rozzano, Italy; ⁹IRCCS Humanitas Research Hospital, Cancer Center, Rozzano, Italy, ¹⁰University of Florence, Department of Experimental and Clinical Biomedical Sciences "Mario Serio", Florence, Italy, ¹¹University Campus Bio-Medico di Roma, Unit of Endocrinology and Diabetes, Department of Medicine, Rome, Italy, ¹²Washington University in St Louis, Division of Bone and Mineral Diseases, St Louis, MO, United States

Management of skeletal fragility in women with early breast cancer (BC) under hormone-deprivation therapies (HDTs) may be a challenge and it is still unknown whether anti-osteoporotic therapies could be active in preventing fractures in pre-menopausal women exposed to HDTs. In this real-world, multicenter study, we evaluated the effectiveness of bone-active drmgs and determinants of vertebral fractures (VFs) in 306 pre-menopausal women (mean age 47.15±5.09, range: 30-54) with early BC treated undergoing HDTs [gonadotropin-releasing hormone agonist (GnRHa) plus aromatase inhibitors (AIs) in 223 cases, GnRHa plus tamoxifene in 26 cases, AIs alone in 53 cases, tamoxifene alone in 4 cases]. In all 306 women, menopause was induced by treatment of BC (chemotherapy in 57 cases; GnRHa in the remaining 249 cases). All enrolled women were retrospectively evaluated for bone mineral density (BMD) and morphometric VFs by 12 months from starting of HDTs and after at least 24 months of treatment. Treatment was guided by national guidelines, current Italian regulation for drmg reimbursement, patient’s preference, comorbidities and overall clinical judgement. After the first bone evaluation, bone-active drmgs were prescribed in 237 women out of 306 (64 oral bisphosphonates, 28 zoledronate 5 mg iv yearly, 145 denosumab 60 mg every 6 months). At baseline, familiar history of osteoporotic fractures, personal history of clinical fractures, osteopenia, osteoporosis and morphometric VFs were found in 41 (13.40%), 21 (6.90%), 172 (56.20%), 39 (12.70%) and 19 (6.20%), respectively. After 47.01±20.10 months of follow-up, 16 women (5.20%) experienced either new VFs or progression of pre-existing VFs. Incident VFs occurred more frequently in women who were untreated as compared to those treated with bone-active drmgs (14/69, 20.80% vs 2/237, 0.80%; P<0.001). Risk of VFs was associated with baseline diagnosis of osteoporosis [odds ratio (OR) 4.14, 95% confidence interval (C.I.) 1.10-15.58; P=0.036), familiar history of osteoporotic fractures (OR 3.19, 95% C.I. 1.05-9.73; P=0.041), baseline morphometric VFs (OR 25.36, 95% C.I. 8.03-80.13; P<0.001) and body mass index (BMI; OR 1.07; 95% C.I. 1.01-1.14; P=0.034). Duration of HDTs was significantly shorter in women experiencing incident VFs with vs those who did not fracture (38.00±16.80 months vs 47.50±20.10 months; P=0.047). In conclusion, risk of VFs in pre-menopausal women exposed to HDTs for early-BC could be effectively prevented by bisphosphonates or denosumab. This study smggests that bone-active drmgs might be indicated in women with pre-existing osteoporosis, familiar history of osteoporotic fractures and in those with higher BMI.