地舒单抗多久打一次？

The application materials submitted to the FDA and the European Medicines Agency (EMA) include 30 clinical studies involving more than 10,500 postmenopausal osteoporosis patients and 1,700 breast and prostate cancer patients receiving hormone deprivation therapy. A 3-year randomized, double-blind, placebo-controlled trial in postmenopausal women with osteoporosis confirmed the efficacy and safety of denosumab.

The study included 7,808 women aged 60 to 90 years who had lumbar spine and hip BMD T-scores between -2.5 and -4.0. Subjects were randomized to receive 60 mg of denosumab or placebo subcutaneously every 6 months for a total of 36 months. The results showed that denosumab reduced the risk of new X-ray lumbar spine fractures by 68% compared with placebo. The risk of hip fracture is reduced by 40% and the risk of non-vertebral fracture is reduced by 20%. The study, published in the New England Journal of Medicine in 2009, coincided with another study of prostate cancer patients receiving androgen deprivation therapy, which showed that denosumab was associated with an increase in bone density at all sites and a decrease in the incidence of new vertebral fractures in these patients compared with placebo.

How often should I take denosumab? Desomasumab injection dosage: Desomasumab should be given as a subcutaneous injection in the upper arm, upper thigh, or abdomen once every 4 weeks. 120 mg/1.7 mL (70 mg/mL) single use vial.

Following its approval by the U.S. Food and Drug Administration (FDA) in November 2010, in July this year, the European Medicines Agency (EMA) also officially approved denosumab for the prevention of SRE in patients with bone metastases from solid tumors. Desosumab is a fully humanized immunoglobulin (Ig) G2 monoclonal antibody prepared using recombinant DNA technology. Its target is receptor activator of nuclear factor-κB ligand (RANKL).