地舒单抗(Xgeva)能治疗男性骨质疏松吗？

Denosumab (Xgeva) treatment can treat osteoporosis in men.

Denosumab (Xgeva) is a drug used to treat osteoporosis. It can not only treat female osteoporosis, but is also effective for male osteoporosis patients. It can slow down bone loss, improve bone mineralization, and reduce the risk of fractures.

About denosumab

Denosumab can treat bone-related events and osteoporosis with a high risk of fracture in patients with bone metastatic solid tumors.

On February 24, 2023, it was approved by the China State Food and Drug Administration for the treatment of osteoporosis in men with high risk of fractures. It can help patients improve bone mass and reduce the risk of fractures. It is currently China's first and only anti-RANKL monoclonal antibody drug used to treat male osteoporosis.

The mechanism of denosumab in treating osteoporosis

Denosumab works by inhibiting the formation and activation of osteoclasts, helping to slow down the loss of bone mass and increase bone density, thereby reducing the risk of fractures. It has shown good results in male patients who have lost bone mass due to disease or other reasons. Clinical studies have shown that denosumab can significantly increase bone mineral density and reduce the risk of vertebral, non-vertebral and hip fractures with long-term treatment.

The effect of denosumab in the treatment of osteoporosis in men

In a global Phase 3 efficacy and safety clinical study, male patients with osteoporosis were included to evaluate the efficacy of denosumab.

The study results show that compared with placebo, denosumab can significantly improve the bone density of key parts such as the lumbar spine, total hip, femoral neck, and femoral trochanter after 12 months of treatment. The bone density continues to increase after 24 months of treatment. The bone density of the lumbar spine and total hip increased by 8% and 3.4% compared with the baseline, and the safety of the drug is good.

Denosumab for the treatment of osteoporosis in women

In a study comparing the efficacy of denosumab or romosozumab in the treatment of postmenopausal osteoporosis for 12 months, 69 patients received denosumab or romosozumab for 12 months respectively. The mean 12-month percentage change in lumbar spine BMD from baseline was 7.2% in the denosumab group and 12.5% ​​in the romosozumab group, with a significant difference between the two groups.

At 12 months, the percentage change in BMD of the total hip and femoral neck was also significantly higher in the romosozumab group than in the denosumab group. In denosumab patients, bone formation and bone resorption markers decreased significantly at 6 and 12 months after baseline. In the romosozumab group, bone formation markers increased significantly at 6 months and then returned to baseline, and bone resorption markers decreased significantly at both time points.

Denosumab reduced the risk of vertebral, non-vertebral and hip fractures and increased BMD at skeletal sites, and these benefits were maintained over 10 years during the extended period of treatment.

Efficacy of denosumab for osteoporosis in the elderly

Even though there is limited evidence on the long-term effectiveness of denosumab in elderly patients, denosumab may still be considered a first-line treatment for elderly patients at high risk for osteoporosis, especially for those who cannot take bisphosphonates.

Denosumab has shown superior results in improving bone density and reducing fracture risk, also in frail older adults. , long-term use of denosumab is safe and effective, and can improve treatment compliance and efficacy.

Usage and dosage for the treatment of osteoporosis

The recommended dose is 60 mg, a single subcutaneous injection of denosumab, once every 6 months, and the injection site includes the thigh, abdomen or upper arm.

References:

Kobayakawa T, Miyazaki A, Saito M, Suzuki T, Takahashi J, Nakamura Y. Denosumab versus romosozumab for postmenopausal osteoporosis treatment. Sci Rep. 2021 Jun 3;11(1):11801. doi: 10.1038/s41598-021-91248-6. PMID: 34083636; PMCID: PMC8175428.

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