title: AI-related BMD variation in actual practice conditions: A prospective cohort study.
abstract: The aim of the study was to evaluate the progression of bone mineral density (BMD) during 3 years of aromatase inhibitors (AI) therapy in actual practice conditions. This prospective, clinical cohort study of Barcelona-Aromatase induced Bone Loss in Early breast cancer (B-ABLE) assessed BMD changes during 3 years of AI treatment in women with breast cancer. Patients with osteoporosis (T score < -2.5 or T score ≤ -2.0) and a major risk factor and/or prevalent fragility fractures were treated with oral bisphosphonates (BPs). Of 685 women recruited, 179 (26.1%) received BP treatment. By the third year of AI therapy, this group exhibited increased BMD in the lumbar spine (LS; 2.59%) and femoral neck (FN; 2.50%), although the increase was significant only within the first year (LS: 1.99% and FN: 2.04%). Despite BP therapy, however, approximately 15% of these patients lost more than 3% of their baseline bone mass. At 3 years, patients without BP experienced BMD decreases in the LS (-3.10%) and FN (-2.79%). In this group, BMD changes occurred during the first (LS: -1.33% and FN: -1.25%), second (LS: -1.19% and FN: -0.82%), and third (LS: -0.57% and FN: -0.65%) years of AI treatment. Increased BMD (>3%) was observed in just 7.6% and 10.8% of these patients at the LS and FN, respectively. Our data confirm a clinically relevant bone loss associated with AI therapy amongst nonusers of preventative BPs. We further report on the importance of BMD monitoring as well as calcium and 25-hydroxy vitamin D supplementation in these patients.
authors.affiliation: IMIM (Hospital del Mar Research Institute)Red Temática de Investigación Cooperativa en Envejecimiento y Fragilidad (RETICEF), Barcelona, Spain.
authors.forename: María
authors.initials: M
authors.lastname: Rodríguez-Sanz
authors.affiliation: IMIM (Hospital del Mar Research Institute)Red Temática de Investigación Cooperativa en Envejecimiento y Fragilidad (RETICEF), Barcelona, Spain IDIAP Jordi Gol Primary Care Research InstituteUniversitat Autònoma de Barcelona, Barcelona, Spain Nuffield Department of OrthopaedicsRheumatology and Musculoskeletal Sciences, Oxford NIHR Musculoskeletal Biomedical Research Unit, University of Oxford, Oxford, UK MRC Lifecourse Epidemiology UnitUniversity of Southampton, Southampton, UK.
authors.forename: Daniel
authors.initials: D
authors.lastname: Prieto-Alhambra
authors.affiliation: Cancer Research ProgramIMIM (Hospital del Mar Research Institute), Medical Oncology Department, Hospital del Mar, Autonomous University of Barcelona, Barcelona, Spain.
authors.forename: Sonia
authors.initials: S
authors.lastname: Servitja
authors.affiliation: IMIM (Hospital del Mar Research Institute)Red Temática de Investigación Cooperativa en Envejecimiento y Fragilidad (RETICEF), Barcelona, Spain ngarcia@imim.es.
authors.forename: Natalia
authors.initials: N
authors.lastname: Garcia-Giralt
authors.affiliation: Cancer Research ProgramIMIM (Hospital del Mar Research Institute), Medical Oncology Department, Hospital del Mar, Autonomous University of Barcelona, Barcelona, Spain.
authors.forename: Laia
authors.initials: L
authors.lastname: Garrigos
authors.affiliation: Internal Medicine DepartmentHospital del Mar, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Jaime
authors.initials: J
authors.lastname: Rodriguez-Morera
authors.affiliation: Cancer Research ProgramIMIM (Hospital del Mar Research Institute), Medical Oncology Department, Hospital del Mar, Autonomous University of Barcelona, Barcelona, Spain.
authors.forename: Joan
authors.initials: J
authors.lastname: Albanell
authors.affiliation: Cancer Research ProgramIMIM (Hospital del Mar Research Institute), Medical Oncology Department, Hospital del Mar, Autonomous University of Barcelona, Barcelona, Spain.
authors.forename: Maria
authors.initials: M
authors.lastname: Martínez-García
authors.affiliation: Cancer Research ProgramIMIM (Hospital del Mar Research Institute), Medical Oncology Department, Hospital del Mar, Autonomous University of Barcelona, Barcelona, Spain.
authors.forename: Iria
authors.initials: I
authors.lastname: González
authors.affiliation: IMIM (Hospital del Mar Research Institute)Red Temática de Investigación Cooperativa en Envejecimiento y Fragilidad (RETICEF), Barcelona, Spain Internal Medicine DepartmentHospital del Mar, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Adolfo
authors.initials: A
authors.lastname: Diez-Perez
authors.affiliation: Cancer Research ProgramIMIM (Hospital del Mar Research Institute), Medical Oncology Department, Hospital del Mar, Autonomous University of Barcelona, Barcelona, Spain.
authors.forename: Ignasi
authors.initials: I
authors.lastname: Tusquets
authors.affiliation: IMIM (Hospital del Mar Research Institute)Red Temática de Investigación Cooperativa en Envejecimiento y Fragilidad (RETICEF), Barcelona, Spain Internal Medicine DepartmentHospital del Mar, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Xavier
authors.initials: X
authors.lastname: Nogués
mesh_terms: D000368:Aged; D047072:Aromatase Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy / Q000503:physiopathology*; D004164:Diphosphonates / Q000627:therapeutic use; D005260:Female; D005272:Femur Neck / Q000502:physiology; D006615:Hip / Q000502:physiology; D006801:Humans; D008159:Lumbar Vertebrae / Q000502:physiology; D008875:Middle Aged; D010024:Osteoporosis / Q000139:chemically induced* / Q000503:physiopathology / Q000517:prevention & control; D011446:Prospective Studies
chemical_list: D047072:Aromatase Inhibitors; D050071:Bone Density Conservation Agents; D004164:Diphosphonates
keywords: 25(OH)vitD; aromatase inhibitors; bisphosphonates; bone loss; breast cancer; osteoporosis