Resumen
Objetivo: Evaluar la eficacia del denosumab en el tratamiento de la osteoporosis posmenopáusica, con énfasis en la densidad mineral ósea y posibles alteraciones metabólicas. Método: Se realizó una revisión integradora de la literatura en las bases de datos PUBMED/MEDLINE, ScienceDirect, SciELO y BVS/LILACS, incluyendo estudios de los últimos 10 años. La recolección de datos se llevó a cabo entre diciembre de 2024 y enero de 2025, utilizando los descriptores “Osteoporosis posmenopáusica”, “Metabolismo” y “Denosumab”. Resultados: Se incluyeron ocho estudios, que abarcaron un total de 33.505 mujeres. Los resultados indican que el denosumab reduce significativamente el riesgo de fracturas osteoporóticas y aumenta la densidad mineral ósea, con una disminución en la actividad osteoclástica, evidenciada por marcadores como la fosfatasa alcalina total y la osteocalcina. También se observó un aumento en los niveles de triglicéridos entre el tercer y sexto mes de uso, lo que indica la necesidad de monitoreo del perfil lipídico. Se registraron casos de hipocalcemia, especialmente en pacientes con comorbilidades o uso concomitante de otros medicamentos. Consideraciones Finales: En comparación con bifosfonatos y placebo, el denosumab mostró buena tolerancia y baja incidencia de efectos adversos graves. Se concluye que el denosumab es una alternativa eficaz y segura para la osteoporosis posmenopáusica, aunque se recomienda vigilancia frente a posibles alteraciones metabólicas.
Referencias
BRASIL. Ministério da Saúde. Protocolo Clínico e Diretrizes Terapêuticas da Osteoporose. Brasília: Ministério da Saúde; 2022. Disponível em: https://www.gov.br/conitec/pt-br/midias/consultas/relatorios/2022/20220919_pcdt_osteoporose.pdf
CRANDALL CJ, et al. Serial bone density measurement and incident fracture risk discrimination in postmenopausal women. JAMA Intern Med, 2020; 180(9): 1232–1240.
EASTELL R, et al. Advances in the treatment of osteoporosis. Lancet, 2019; 393(10169): 364–76. doi:10.1016/S0140-6736(18)32112-3
FERRARI S, et al. Denosumab in postmenopausal women with osteoporosis and diabetes: subgroup analysis of FREEDOM and FREEDOM extension. Bone, 2020; 134: 115268.
FOOD AND DRUG ADMINISTRATION (FDA). Approves new injectable treatment for osteoporosis for postmenopausal women. FDA; 2010. Disponível em: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm214150.htm
HAJISADEGHI H, et al. Effect of regular resistance exercise, vitamin D, and calcium supplements on the bone mineral content and density in postmenopausal model of rats. Int J Reprod Biomed, 2021; 19(1): 63–74.
HEALTH CANADA. Summary Basis of the Decision-PROLIA. 2011. Disponível em: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodpharma/sbd-smd/phase1-decision/drugmed/sbd_smd_2011_prolia_121139-eng.pdf
INTERNATIONAL OSTEOPOROSIS FOUNDATION. Epidemiology of osteoporosis and fragility fractures [Internet]. 2025. Disponível em: https://www.osteoporosis.foundation/facts-statistics/epidemiology-of-osteoporosis-and-fragility-fractures
KIM KJ, et al. A simple-to-use score for identifying individuals at high risk of denosumab-associated hypocalcemia in postmenopausal osteoporosis: a real-world cohort study. Calcif Tissue Int, 2020; 107(6): 567–575.
KOH JM, et al. Assessment of denosumab in Korean postmenopausal women with osteoporosis: randomized, double-blind, placebo-controlled trial with open-label extension. Yonsei Med J, 2016; 57(4): 905–914.
LAI EC, et al. Effectiveness of denosumab for fracture prevention in real-world postmenopausal women with osteoporosis: a retrospective cohort study. Osteoporos Int, 2022; 33(5): 1155–1164.
LASCO A, et al. Inhibition of RANKL denosumab and insulin resistance in postmenopausal women with osteoporosis. Calcif Tissue Int, 2016; 98(2): 123–8.
MORGAN KP, et al. Denosumab for first-line treatment of hypercalcemia associated with malignancy: retrospective analysis. J Hematol Oncol Pharm, 2021; 11(3): 121–126.
NORTH AMERICAN MENOPAUSE SOCIETY. Menopause practice: a clinical guide. 6th ed. 2022.
PAGE MJ, et al. A declaração PRISMA 2020: diretriz atualizada para relatar revisões sistemáticas. Epidemiol Serv Saude, 2022; 31(2).
PAPAPOULOS S, et al. Five years of denosumab exposure in women with postmenopausal osteoporosis: results from the first two years of the FREEDOM extension. J Bone Miner Res, 2012; 27(3): 694–701. doi:10.1002/jbmr.1479.
PAPAPOULOS S, et al. The effect of 8 or 5 years of denosumab treatment in postmenopausal women with osteoporosis: results from the FREEDOM Extension study. Osteoporos Int, 2015; 26(12): 2773–83.
ROSEN CJ. The epidemiology and pathogenesis of osteoporosis. Endotext. South Dartmouth (MA): MDText.com, Inc.; 2020.
RŮŽIČKOVÁ O, et al. Real-world management of postmenopausal osteoporosis women treated with denosumab: a prospective observational study in the Czech Republic and Slovakia. Adv Ther, 2018; 35(10): 1713–28.
SÁNCHEZ A, et al. Effect of denosumab on bone mineral density and bone turnover markers among postmenopausal women with osteoporosis. J Osteoporos, 2016; 2016: 8738959.
SÃO PAULO STATE DEPARTMENT OF HEALTH. PTC Denosumab. São Paulo: São Paulo State Department of Health; 2015. Disponível em: https://www.saude.sp.gov.br/resources/instituto-de-saude/homepage/pdfs/ptc_denosumabe_final_comcapa.pdf
TSVETOV G, et al. Denosumab-induced hypocalcemia in patients with osteoporosis. Osteoporos Int, 2020; 31(4): 655–665.
WU CH, et al. Pharmacologic intervention for prevention of fractures in osteopenic and osteoporotic postmenopausal women: Systemic review and meta-analysis. Bone Rep, 2020.
