Zoledronato: El tratamiento anual para la osteoporosis posmenopáusica

El zoledronato (o ácido zoledrónico) ha recibido la autorización de la FDA norteamericana para el tratamiento de la osteoporosis posmenopáusica, mediante una dosis única anual.

La osteoporosis (literalmente "huesos porosos") se produce cuando se altera la estructura y la resistencia, con el correspondiente riesgo de sufrir fracturas ante traumatismos de pequeña energía. También se le llama, la enfermedad de los huesos de cristal por la facilidad de sufrir fracturas que a veces no se llegan a diagnosticar pero que causan numerosos síntomas. Las causas de la osteoporosis son genéticas, relacionadas con la alimentación, estilo de vida, edad y hormonas. El Instituto de la Salud de EEUU calcula que existen 34 millones de norteamericanas con riesgo de osteoporosis, y cada año se producen un millón y medio de fracturas relacionadas con la osteoporosis.

Leo Schargorodski, director de la National Osteoporosis Foundation (NOF) de EEUU ha dicho que "zoledronato (Reclast) es bienvenido como un nuevo tratamiento para la osteoporosis". Zoledronato pertenece al grupo de fármacos denominados bifosfonatos, y se puede administrar mediante inyección intravenosa en 15 minutos una vez al año. La Dra.Felicia Cosman, Profesor de la Universidad deColumbia University de Nueva York, cree que el nuevo fármaco puede ser un hito en el tratamiento de la osteoporosis ya que la paciente tiene la garantía de recibir el medicamento para todo un año de protección.

Más información: First ever once-a-year osteoporosis drug approved, Medical News Today, FDA oks Reclast as once-yearly osteoporosis drug

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Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis.
Black DM, Delmas PD, Eastell R, Reid IR, Boonen S, Cauley JA, Cosman F, Lakatos P, Leung PC, Man Z, Mautalen C, Mesenbrink P, Hu H, Caminis J, Tong K, Rosario-Jansen T, Krasnow J, Hue TF, Sellmeyer D, Eriksen EF, Cummings SR; HORIZON Pivotal Fracture Trial.
University of California, San Francisco, San Francisco, CA 94107, USA. dblack@psg.ucsf.edu
BACKGROUND: A single infusion of intravenous zoledronic acid decreases bone turnover and improves bone density at 12 months in postmenopausal women with osteoporosis. We assessed the effects of annual infusions of zoledronic acid on fracture risk during a 3-year period. METHODS: In this double-blind, placebo-controlled trial, 3889 patients (mean age, 73 years) were randomly assigned to receive a single 15-minute infusion of zoledronic acid (5 mg) and 3876 were assigned to receive placebo at baseline, at 12 months, and at 24 months; the patients were followed until 36 months. Primary end points were new vertebral fracture (in patients not taking concomitant osteoporosis medications) and hip fracture (in all patients). Secondary end points included bone mineral density, bone turnover markers, and safety outcomes. RESULTS: Treatment with zoledronic acid reduced the risk of morphometric vertebral fracture by 70% during a 3-year period, as compared with placebo (3.3% in the zoledronic-acid group vs. 10.9% in the placebo group; relative risk, 0.30; 95% confidence interval [CI], 0.24 to 0.38) and reduced the risk of hip fracture by 41% (1.4% in the zoledronic-acid group vs. 2.5% in the placebo group; hazard ratio, 0.59; 95% CI, 0.42 to 0.83). Nonvertebral fractures, clinical fractures, and clinical vertebral fractures were reduced by 25%, 33%, and 77%, respectively (P<0.001 for all comparisons). Zoledronic acid was also associated with a significant improvement in bone mineral density and bone metabolism markers. Adverse events, including change in renal function, were similar in the two study groups. However, serious atrial fibrillation occurred more frequently in the zoledronic acid group (in 50 vs. 20 patients, P<0.001). CONCLUSIONS: A once-yearly infusion of zoledronic acid during a 3-year period significantly reduced the risk of vertebral, hip, and other fractures.

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