Denosumab治疗骨转移疗效怎么样呢？

It is the first approved monoclonal antibody specifically targeting RANK ligand. RANK ligand is a transmembrane or soluble protein that is necessary for osteoclasts to maintain their structure, function, and survival. Human RANKL mRNA is mainly found in bones, bone marrow and lymphoid tissues. Its main function in bones is to stimulate the differentiation and activity of osteoclasts and inhibit the apoptosis of osteoclasts.

Denosumab is a newly approved drug for the treatment of bone metastasis. How effective is Denosumab in treating bone metastasis?

A 3-year randomized, double-blind, placebo-controlled phase III clinical trial FREEDOM evaluated the efficacy and safety of denosumab in the treatment of osteoporosis in postmenopausal women. Patients were randomly divided into treatment groups: Denosumab 60 mg subcutaneous injection 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 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 were also supplemented with 1000 mg of vegetarian calcium and 400 to 800 IU of vitamin D every day.

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), the incidence of hip fractures was reduced by 40% (0.7% in the treatment group and 1.2% in the placebo group), and the incidence of non-vertebral fractures was reduced by 20% (6.5% in the treatment group and 8.0% in the placebo group).