地诺单抗的治疗效果好吗？

(Denosumab) is a human immunoglobulin G2 (IgG2) monoclonal antibody with high specificity and affinity for RANKL. RANK receptor signaling promotes osteolysis and tumor growth. Desosumab inhibits tumor growth and reduces bone destruction by binding to RANKL and preventing it from activating RANK on the surface of osteoclasts, osteoclast precursors and osteoclast-like giant cells. The FDA approved this product for use in postmenopausal women with osteoporosis who are at high risk of fracture. It can help reduce the incidence of vertebral, non-vertebral and hip fractures in postmenopausal women with osteoporosis. This product is also used in patients for whom other current treatments are ineffective or intolerable to reduce the risk of fractures.

Is denosumab effective? 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 effectiveness and safety of denosumab in the treatment of osteoporosis in postmenopausal women.

Patients were randomly assigned to: treatment group (60 mg subcutaneous injection of this product every 6 months, n = 3902) or placebo (n = 3906). The primary evaluation indicator was the incidence of new vertebral fractures during the 3-year period, and secondary indicators included the incidence of hip fractures and non-vertebral 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. 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% (the treatment group was 2.3%, the placebo group was 7.2%, P < 0.000 1), the incidence of hip fractures was relatively reduced by 40% (the treatment group was 0.7%, the placebo group was 1.2%, P = 0.036), and the incidence of non-vertebral fractures was relatively reduced by 20% (the treatment group was 6.5%) , 8.0% in the placebo group, P =0.011). The above is the relevant content of the treatment effect. For more details, please consult the medical companion passenger service.