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J Bone Miner Res ; 25(1): 72-81, 2010 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-19594293

RESUMEN

Patients treated with bisphosphonates for osteoporosis may discontinue or require a switch to other therapies. Denosumab binds to RANKL and is a potent inhibitor of bone resorption that has been shown to increase bone mineral density (BMD) and decrease fracture risk in postmenopausal women with osteoporosis. This was a multicenter, international, randomized, double-blind, double-dummy study in 504 postmenopausal women > or = 55 years of age with a BMD T-score of -2.0 or less and -4.0 or more who had been receiving alendronate therapy for at least 6 months. Subjects received open-label branded alendronate 70 mg once weekly for 1 month and then were randomly assigned to either continued weekly alendronate therapy or subcutaneous denosumab 60 mg every 6 months and were followed for 12 months. Changes in BMD and biochemical markers of bone turnover were evaluated. In subjects transitioning to denosumab, total hip BMD increased by 1.90% at month 12 compared with a 1.05% increase in subjects continuing on alendronate (p < .0001). Significantly greater BMD gains with denosumab compared with alendronate also were achieved at 12 months at the lumbar spine, femoral neck, and 1/3 radius (all p < .0125). Median serum CTX levels remained near baseline in the alendronate group and were significantly decreased versus alendronate (p < .0001) at all time points with denosumab. Adverse events and serious adverse events were balanced between groups. No clinical hypocalcemic adverse events were reported. Transition to denosumab produced greater increases in BMD at all measured skeletal sites and a greater reduction in bone turnover than did continued alendronate with a similar safety profile in both groups.


Asunto(s)
Alendronato/farmacología , Anticuerpos Monoclonales/farmacología , Conservadores de la Densidad Ósea/farmacología , Densidad Ósea/efectos de los fármacos , Remodelación Ósea/efectos de los fármacos , Posmenopausia/efectos de los fármacos , Ligando RANK/farmacología , Anciano , Alendronato/efectos adversos , Alendronato/uso terapéutico , Anticuerpos Monoclonales/efectos adversos , Anticuerpos Monoclonales Humanizados , Biomarcadores/sangre , Conservadores de la Densidad Ósea/efectos adversos , Colágeno Tipo I/sangre , Demografía , Denosumab , Femenino , Cuello Femoral/efectos de los fármacos , Cadera , Humanos , Vértebras Lumbares/efectos de los fármacos , Persona de Mediana Edad , Fragmentos de Péptidos/sangre , Péptidos/sangre , Posmenopausia/sangre , Procolágeno/sangre , Ligando RANK/efectos adversos
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