Long-Term Efficacy of Zoledronate in Reducing Fracture Risk and Improving Bone Density in Postmenopausal Women
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Reviewed by Dat Tien Nguyen, B.A, ScM.
Translated by Nhi Phuong Quynh Le, B.A |
Posted on February 10th, 2025
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Bone density reduction is a common issue for women entering menopause, which increases the risk of fractures as they age. To reduce this risk, interventions aimed at preventing or slowing bone loss should be considered. A study funded by the Health Research Council of New Zealand investigated the effectiveness of zoledronate in reducing the risk of fractures in postmenopausal women.
The clinical trial involved 1,054 women with an average age of 56 who had undergone menopause. Baseline bone density measurements were taken, revealing an average lumbar spine density of 1.13 g/square meter and a total hip density of 0.94 g/square meter. Participants with a bone density T-score below -2.5 were selectively excluded, with a T-score above -1 were considered healthy.
The participants were randomly assigned to one of three treatment schedules: two doses of placebo, two doses of 5-mg zoledronate, or an initial dose of 5-mg zoledronate followed by one dose of placebo. The medication and placebo were administered intravenously, with a 5-year gap between doses. Zoledronate is a bisphosphonate that is absorbed by osteoclasts, which are specialized cells responsible for bone breakdown and material resorption. Once inside osteoclasts, zoledronate disrupts lipid synthesis and prevents post-translational protein modifications. As a result, zoledronate induces apoptosis in osteoclasts and slows down the bone resorption process.
After 10 years of follow-up, the researchers found that zoledronate use reduced the overall risk of fractures by 34% in the two-dose group and 26% in the single-dose group. The reduction in the risk of morphometric vertebral fractures was the most significant, with a decrease of around 50%, while the risk of fragility and osteoporotic fractures was reduced by approximately 30%. Bone density measurements at the 10-year mark showed a 3% increase in the two-dose group, whereas the placebo group experienced a cumulative loss of about 6% over the 10 years. However, the single-dose group was less effective, as the bone density gains were not sustained beyond the fifth year.
The clinical trial involved 1,054 women with an average age of 56 who had undergone menopause. Baseline bone density measurements were taken, revealing an average lumbar spine density of 1.13 g/square meter and a total hip density of 0.94 g/square meter. Participants with a bone density T-score below -2.5 were selectively excluded, with a T-score above -1 were considered healthy.
The participants were randomly assigned to one of three treatment schedules: two doses of placebo, two doses of 5-mg zoledronate, or an initial dose of 5-mg zoledronate followed by one dose of placebo. The medication and placebo were administered intravenously, with a 5-year gap between doses. Zoledronate is a bisphosphonate that is absorbed by osteoclasts, which are specialized cells responsible for bone breakdown and material resorption. Once inside osteoclasts, zoledronate disrupts lipid synthesis and prevents post-translational protein modifications. As a result, zoledronate induces apoptosis in osteoclasts and slows down the bone resorption process.
After 10 years of follow-up, the researchers found that zoledronate use reduced the overall risk of fractures by 34% in the two-dose group and 26% in the single-dose group. The reduction in the risk of morphometric vertebral fractures was the most significant, with a decrease of around 50%, while the risk of fragility and osteoporotic fractures was reduced by approximately 30%. Bone density measurements at the 10-year mark showed a 3% increase in the two-dose group, whereas the placebo group experienced a cumulative loss of about 6% over the 10 years. However, the single-dose group was less effective, as the bone density gains were not sustained beyond the fifth year.