地舒单抗作用功效

(denosumab, also known as AMC-162, trade name Prolia) is a bone resorption inhibitor with a unique mechanism of action. It specifically targets the receptor activator of NF-kB ligand (RANKL), inhibits the activation and development of osteoclasts, reduces bone resorption, and increases bone density.

On May 28, 2010, the European Commission approved denosumab for the treatment of bone loss associated with hormone suppression in postmenopausal women with osteoporosis and prostate cancer. It can also be used in patients who are currently ineffective or intolerant to other treatments to reduce the risk of fractures.

What is the function of denosumab? A 3-year randomized, double-blind, placebo-controlled phase III clinical trial FREEDOM (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) evaluated the efficacy and safety of denosumab in the treatment of osteoporosis in postmenopausal women.

Patients were randomly assigned to treatment (desomasumab 60 mg subcutaneously every 6 months, n = 3902) or placebo (n = 3906). The primary outcome measure was the incidence of new vertebral fractures over the 3-year period, and secondary outcomes included the incidence of hip and nonvertebral fractures and the time to first fracture during the observation period. The subjects were aged between 60 and 90 years old, with an average age of 72.3 years. The basic value of spine or total hip T-score was between -4.0 and -2.5 (the average was -2.8). About 23% of the subjects had a history of at least one fracture before entering this trial. All patients also received daily supplements of 1,000 mg of vegetarian calcium and 400 to 800 IU of vitamin D.

The results showed that compared with the placebo group, the incidence of new vertebral fractures in the treatment group was reduced by 68% (2.3% in the treatment group, 7.2% in the placebo group, P < 0.0001), the incidence of hip fractures was relatively reduced by 40% (0.7% in the treatment group, 1.2% in the placebo group, P = 0.036), and the incidence of non-vertebral fractures was relatively reduced. 20% (6.5% in the treatment group and 8.0% in the placebo group, P =0.011).

From the above tests, it can be clearly seen that the effect is very outstanding and significantly reduces the patient's fracture risk.