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狄诺塞麦可以治疗什么病症呢?

Author: Medicalhalo
Release time: 2025-10-19 11:44:20

What conditions can be treated? In June 2010, the FDA approved denosumab for the treatment of osteoporosis in postmenopausal women, and was later approved for the treatment of osteoporosis in men, bone loss caused by androgen deprivation therapy for prostate cancer, and bone loss caused by aromatase inhibitor therapy for breast cancer. On May 27, 2019, Amgen China announced today that denosumab has been approved by the National Medical Products Administration for the treatment of giant cell tumors of bone that are unresectable or that may result in severe functional disability after surgical resection, including adults and adolescent patients with skeletal maturity (defined as at least 1 mature long bone and body weight >45 kg).

Results from a Phase 4 study of Amgen's denosumab demonstrated greater increases in bone density compared with the intravenous bisphosphonate zoledronic acid in postmenopausal women with osteoporosis previously treated with an oral bisphosphonate.

The study involved 643 women aged 55 years or older who were randomly assigned in a 1:1 ratio to receive either subcutaneous denosumab (injected every 6 months) plus intravenous placebo (injected once a year) or intravenous zoledronic acid (injected once a year) plus subcutaneous placebo (injected once every 6 months). The study's primary endpoint was change from baseline in lumbar spine BMD at 12 months of treatment, which showed a significantly greater increase in BMD in the denosumab group compared with the zoledronic acid group.

The treatment group also had significantly greater improvements than the zoledronic acid treatment group on secondary and exploratory study endpoints, including changes in overall BMD at the hip, femoral neck, and 1/3 of the radius. These results add to existing evidence supporting denosumab as an important treatment option for postmenopausal women with osteoporosis, particularly those who have failed bisphosphonate therapy.

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