Predictive Value of Bone Turnover Markers During Discontinuation With Alendronate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- If Carboxy-terminal Collagen Crosslinks (CTX) Three and Six Months After Stopping Alendronate Predicted TH BMD (Total Hip BMD) Loss Above the Least Significant Change at Month 12 at the Individual Level.
研究概览
简要总结
The study is a cohort study comprising 136 patients with osteoporosis stopping treatment with alendronate. The study will contribute with new knowledge about biochemical markers of bone turnover as predictors of bone loss after stopping treatment with alendronate.
详细描述
Background:
Osteoporosis increases the risk of fractures. Alendronate reduces the risk of both vertebral- and hip fractures by approximately 50%. It has, however, become evident that long-term anti-resorptive may lead to serious side effects such as atypical femoral fractures or osteonecrosis of the jaw. The alendronate extension study (FLEX) showed that despite stopping treatment after five years the anti-fracture efficacy regarding non-vertebral and radiological vertebral fractures persists for an additional five years in patients with bone mineral density (BMD) T-score > -2.5 at the femoral neck, no fractures during treatment, and no previous vertebral fracture. It is therefore now clinical practice, that treatment is discontinued after five years in patients that fulfil these criteria. Based on the alendronate extension study it was assumed, that bone turnover monitored by biochemical markers would stay suppressed for years after stopping treatment, however, other studies have demonstrated that there is a great variability in the change in bone turnover markers seen after stopping treatment with alendronate in a real-life setting.
Aim:
To investigate the predictive value of markers of bone turnover on bone loss 12 months after stopping alendronate therapy.
Methods:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women (postmenopausal for at least two years)
- •Men above 50 years
- •Treatment for at least five years with alendronate
- •BMD T-score total hip > -2.5
- •BMD T-score lumbar spine (L1-L4) > -4
排除标准
- •Any low-energy fracture within the previous five years during alendronate treatment (not including fingers, toes, or skull)
- •Low-energy vertebral fracture at any time
- •Low-energy hip fracture at any time
- •Ongoing treatment with glucocorticoids
- •Metabolic bone disease
- •Hormone replacement therapy
- •Other conditions affecting bone metabolism
结局指标
主要结局
If Carboxy-terminal Collagen Crosslinks (CTX) Three and Six Months After Stopping Alendronate Predicted TH BMD (Total Hip BMD) Loss Above the Least Significant Change at Month 12 at the Individual Level.
时间窗: Baseline and one year after baseline
We constructed receiver operating characteristic (ROC) curves to evaluate if carboxy-terminal collagen crosslinks (CTX) three and six months after stopping alendronate predicted TH BMD loss above the least significant change (LSC) at month 12 at the individual level.
次要结局
- Percent Change in Bone Turnover Markers Measured Three and Six Months After Stopping Alendronate Treatment and BMD After One and Two Years(one and two years after baseline)
- Number of Participants in Which CTX Increased Above the Least Significant Change(From baseline to month 24)
- The Number of Participants Who Lost BMD Beyond the Least Significant Change (LSC) at the Lumbar Spine and Total Hip.(from baseline to month 24)
- If Baseline Bone Turnover Markers at the Time of Alendronate Discontinuation Predict Changes in BMD After One and Two Years.(Changes in TH BMD after one and two years.)
研究者
Anne Sophie Sølling
MD, PhD student
Aarhus University Hospital