The Effect of Zoledronic Acid Infusion in the Bone Loss Observed Following Denosumab Discontinuation in Postmenopausal Women With Low Bone Mass
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- bone mineral density of the lumbar spine
研究概览
简要总结
In contrast with bisphosphonates,discontinuation of denosumab results in gradual loss of bone mineral density gains. The investigators aim to evaluate whether in patients treated with denosumab, a single zoledronic acid infusion would prevent the anticipated bone loss.
详细描述
Discontinuation of denosumab results in a rebound rise of bone turnover markers and gradual loss of the achieved bone mineral density gains. In contrast, bisphosphonates, such as zoledronic acid, remain within the skeleton acting for several months or even years after discontinuation while maintaining bone mineral density despite the cessation of treatment. In this study, the investigators aim to evaluate changes in bone mineral density of the lumbar spine and the femoral neck, as well as in bone turnover markers one year after treatment discontinuation both in denosumab-treated women and in denosumab-treated women who switched to zoledronic acid infusion one year before treatment discontinuation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •postmenopausal women
- •osteopenic (T-score > -2.5 but < -1.0) after treatment with denosumab
排除标准
- •secondary osteoporosis;
- •diseases that could affect bone metabolism;
- •medications that could affect bone metabolism;
- •history of any antiosteoporotic treatment other than denosumab prior to randomization
- •severe liver or kidney disease (creatinine clearance < 60ml/min/1.73m2)
研究组 & 干预措施
Denosumab
Patients with low bone mass, being treated only with denosumab in the past, who will receive another year of treatment with denosumab and subsequently discontinue treatment for one year
干预措施: Denosumab (Drug)
Denosumab plus zoledronic acid
Patients with low bone mass, being treated only with denosumab in the past, who will receive a single infusion of zoledronic acid and subsequently discontinue treatment for another year
干预措施: Zoledronic acid (Drug)
结局指标
主要结局
bone mineral density of the lumbar spine
时间窗: from 12 to 24 months
differences between the 2 arms in the changes of lumbar spine bone mineral density measured by dual-energy X-ray absorptiometry
次要结局
- bone mineral density of the femoral neck(from baseline to 12 months)
- C-terminal telopeptide of type I collagen(from 12 to 15, 18, 24 months)
- propeptide of procollagen type I(from 12 to 15, 18, 24 months)
- bone mineral density of the lumbar spine(from baseline to 12 months)
研究者
Athanasios D. Anastasilakis
Consultant of Endocrinology
424 General Military Hospital