地诺单抗治疗骨转移效果如何呢？

How effective is the treatment of bone metastases? This is what most patients are most concerned about after denosumab is launched. Denosumab is a bone resorption inhibitor with a unique mechanism of action. Let’s learn from the most direct and concise trial data about the effect of denosumab in treating bone metastasis.

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 group (denosumab 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 T-score value of the spine or total hip 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), the incidence of hip fractures was relatively reduced by 40% (0.7% in the treatment group and 1.2% in the placebo group, P = 0.036), and 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).

From the above tests, we can clearly see that it effectively reduces the progression of the disease and has an obvious effect in treating bone metastasis.