The Effectiveness of Single or Repeat Zoledronate Infusion Versus Oral Alendronate in Consolidating the Bone Accrual Achieved With Denosumab: a Study Organised by the European Calcified Tissue Society
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 122
- 试验地点
- 18
- 主要终点
- lumbar spine BMD
研究概览
简要总结
A 24-month prospective, open-label, randomized, multicenter, multinational, non-inferiority pragmatic clinical trial evaluating zoledronate single or double infusion versus oral alendronate following denosumab
详细描述
125 postmenopausal women treated with Dmab for 3 or more years who will reach osteopenia with denosumab will be randomized into three groups: i) zoledronate infusion (5mg) at 6 months after last Dmab dose (single Zol group) ii) zoledronate infusion (5mg) at 6 and 12 months after last Dmab dose (double Zol group) iii) alendronate 70mg orally weekly for 12 months (ALN group) All women will receive no further treatment during the 2nd year of the study.
Participating centers: ECTS affiliated bone centers
Endpoints: Primary: BMD changes at the lumbar spine at 12 months. Secondary: i) BMD changes at the lumbar spine at 24 months; ii) BMD changes at the non-dominant femoral neck and total hip at 12 and 24 months; iii) changes at levels of bone turnover markers throughout the study; iv) incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral; v) clinical parameters: height change, VAS for back pain, and use of analgesics
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 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women treated with denosumab for 3 or more years who will reach osteopenia
排除标准
- •a bone disease other than postmenopausal osteoporosis
- •use of medications other than bisphosphonates or SERMS affecting bone metabolism during the last 12 months before entering the study
- •creatinine clearance <60 mL/min/1.73 m2
- •liver failure
- •any type of cancer
- •uncontrolled endocrine diseases
- •serum 25-hydroxy vitamin D (25-OHD) concentrations lower than 20 ng/mL (50 nmol/L)
研究组 & 干预措施
single Zol group
postmenopausal women treated with denosumab for 3 or more years who will reach osteopenia with denosumab and will receive a single zoledronate infusion (5mg) at 6 months after the last denosumab dose
干预措施: Zoledronate or Alendronate (Drug)
double Zol group
postmenopausal women treated with denosumab for 3 or more years who will reach osteopenia with denosumab and will receive two zoledronate infusions (5mg) at 6 and 12 months after the last denosumab dose
干预措施: Zoledronate or Alendronate (Drug)
ALN group
postmenopausal women treated with denosumab for 3 or more years who will reach osteopenia with denosumab and will receive alendronate 70mg orally weekly for 12 months
干预措施: Zoledronate or Alendronate (Drug)
结局指标
主要结局
lumbar spine BMD
时间窗: 24 months
BMD changes at the lumbar spine at 12 and 24 months
次要结局
- fracture(24 months)
- height(24 months)
- P1NP(baseline, 3 months, 6 months, 12 months, 18 months, 24 months)
- CTx(24 months)
- femoral neck BMD(24 months)
研究者
Athanasios D. Anastasilakis
Consultant of endocrinology; in charge of the Department of Metabolic Bone Diseases
424 General Military Hospital