地诺单抗（狄诺塞麦）治疗效果好吗？

It is a human immunoglobulin G2 (IgG2) monoclonal antibody with high specificity and affinity for RANKL. RANK receptor signaling promotes osteolysis and tumor growth.

A randomized, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of this product in the treatment of osteoporosis in postmenopausal women. Patients were randomly divided into 7 denosumab (denosumab) treatment groups [41 to 54 subjects in each group, receiving subcutaneous injection of denosumab 6, 14, 30 mg (all once every 3 months), 14, 60, 100 or 210 mg (all once every 6 months)], and a positive control group (orally administered alendronate sodium 70 mg, once a week) and placebo group. The main evaluation index is the change of the patient's spinal bone mineral density (BMD) from the baseline level after treatment. The results showed that after 12 months, compared with the baseline level, the spinal BMD of patients in the treatment group increased by 3.0% to 6.7%, that in the control group increased by 4.6%, and that in the placebo group decreased by 0.8% (P < 0.001). After 24 months, the spinal BMD of patients in the treatment group increased by 4.13% to 8.89%, while that in the placebo group decreased by 1.18%. The BMD of the hip and distal 1/3 of the radius in the treatment group was also significantly increased compared with the placebo. During this period, there were no significant differences in patient tolerability, BTM levels, and adverse reaction rates between groups. Among the 7 treatment groups, the 60 mg (once every 6 months) group has an ideal balance point in terms of safety and efficacy, and this dose will continue to be used in Phase III clinical trials in the future.

A one-year, double-blind, randomized controlled phase III clinical trial DECIDE (Determining Efficacy: Comparison of Initiating Denosumab versus alEndronate) compared the effectiveness and safety of this product and alendronate. A total of 1189 postmenopausal women were enrolled. The average baseline T-score of the lumbar spine of the enrolled patients was -2.6, and the average age was 64 years old. Patients were randomly divided into: treatment group (60 mg subcutaneous injection of this product, once every 6 months, n = 594), control group (oral alendronate sodium 70 mg, once every 6 months, n = 595). All subjects were supplemented with 500 mg of calcium per day, and the dose of vitamin D was adjusted based on plasma 25-hydroxyvitamin D levels. After 12 months, it can be observed that the BMD of both groups increased at all detection sites (hip, spine, femoral neck, trochanter, and distal 1/3 of the radius), but the increase in the treatment group was more significant than that of the control group (the primary endpoint of total hip BMD increased by 3.5 and 2.6, respectively, P <0. 000 1). The incidence of adverse reactions was similar between the two groups. A questionnaire survey of patients showed that the majority of patients (77%) preferred to receive treatment with subcutaneous injections twice a year.