Austin Health, University of Melbourne, Melbourne, Australia.
Bone. 2010 Apr;46(4):1038-42. doi: 10.1016/j.bone.2009.12.006. Epub 2009 Dec 21.
Longevity has resulted in a greater proportion of the population entering a time of life when increasing bone fragility and falls predispose to fractures, particularly nonvertebral fractures. Women over 80 years of age constitute 10% of the population but contribute 30% of all fractures and 60% of all nonvertebral fractures. Despite this, few studies have examined antifracture efficacy of treatments in this high-risk group and none has provided evidence for benefits beyond 3 years.
To determine whether strontium ranelate reduces the risk of vertebral and nonvertebral fractures during 5 years, we analyzed a subgroup of 1489 female patients over 80 years of age (mean 83.5+/-3.0 years) with osteoporosis from the SOTI (spinal osteoporosis therapeutic intervention) and TROPOS (treatment of peripheral osteoporosis) studies randomized to strontium ranelate 2 g/d or placebo. All received a supplement of calcium plus vitamin D.
By intention to treat, vertebral fracture risk was reduced by 31% (relative risk, RR=0.69; 95% confidence interval, CI 0.52-0.92), nonvertebral fracture risk by 27% (RR=0.73; 95% CI 0.57-0.95), major nonvertebral fracture risk by 33% (RR=0.67; 95% CI 0.50-0.89) and hip fracture risk by 24% (RR=0.76; 95% CI 0.50-1.15, not significant). Treatment was cost-saving as it decreased cost and increased QALYs and life-years.
Strontium ranelate safely produced a significant reduction in vertebral and nonvertebral fracture risk during 5 years in postmenopausal women over 80 years of age and was cost saving.
长寿导致更多的人进入生命的一个阶段,在这个阶段,骨脆性增加和跌倒容易导致骨折,特别是非椎体骨折。80 岁以上的女性占人口的 10%,但她们占所有骨折的 30%,占所有非椎体骨折的 60%。尽管如此,很少有研究检查过治疗这种高风险人群的抗骨折疗效,也没有研究提供超过 3 年的益处证据。
为了确定雷奈酸锶是否能降低 5 年内椎体和非椎体骨折的风险,我们分析了 SOTI(脊柱骨质疏松治疗干预)和 TROPOS(外周骨质疏松治疗)研究中随机分配到雷奈酸锶 2g/d 或安慰剂的 1489 名 80 岁以上(平均 83.5+/-3.0 岁)骨质疏松症女性患者的一个亚组。所有患者均接受钙加维生素 D 补充剂。
根据意向治疗,椎体骨折风险降低了 31%(相对风险,RR=0.69;95%置信区间,CI 0.52-0.92),非椎体骨折风险降低了 27%(RR=0.73;95% CI 0.57-0.95),主要非椎体骨折风险降低了 33%(RR=0.67;95% CI 0.50-0.89),髋部骨折风险降低了 24%(RR=0.76;95% CI 0.50-1.15,无统计学意义)。治疗是节省成本的,因为它降低了成本,增加了 QALYs 和寿命。
雷奈酸锶在 5 年内安全地降低了 80 岁以上绝经后女性的椎体和非椎体骨折风险,并且节省了成本。