地舒单抗治疗骨转移疗效怎样？

How effective is the treatment of bone metastases?

The therapeutic effect of denosumab in the treatment of bone metastases:

FREEDOM, a 3-year randomized, double-blind, placebo-controlled phase III clinical trial, evaluated the efficacy and safety of denosumab in the treatment of osteoporosis in postmenopausal women.

Patients were randomized to treatment (desosomeumab 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 spine or total hip T-score value 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 1000 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 and 7.2% in the placebo group, P < 0.000 1), and the incidence of hip fractures was reduced by 40% (0.7% in the treatment group and 1.2% in the placebo group, P = 0.036), the incidence of non-vertebral fractures was relatively reduced by 20% (6.5% in the treatment group and 8.0% in the placebo group, P =0.011).

In addition, a phase I clinical study conducted in healthy postmenopausal women showed that a dose-dependent decrease in morning urine NTX levels could be observed 2 days after administration, and this decrease could last for 6 months, with the maximum decrease reaching 84% compared with baseline. This effect is reversible. When serum levels disappear, NTX levels can be seen to rise again, which reflects the reversibility of its effect on bone reconstruction. As treatment continues, these effects will persist for a new cycle.