Assessment of 4 Bone Turnover Markers (C-terminal Telopeptides of Type I Collagene (CTX), Amino-terminal Telopeptide of Type 1 Collagen (NTX), Dickkopf-1 (DKK-1) and Sclerostin (SOST)) in Multiple Myeloma Patients Treated With Intravenous Bisphosphonate
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Changes in bone turnover markers
研究概览
简要总结
The aim of this study is looking at the Kinetics of bone turnover markers (C-terminal telopeptides of type I collagene (CTX), amino-terminal telopeptide of type 1 collagen (NTX), Dickkopf-1 (DKK-1) and Sclerostin (SOST)) in serum and urine until 12 months in Patients with Multiple Myeloma Treated With intravenous bisphosphonates in routine care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 75 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 65 to 75 years of age
- •Patient with symptomatic multiple myeloma as defined by the criteria of the IMWG
- •Need to introduced an antiresorptive bone treatment by intravenous bisphosphonate with bone imaging mapping (PET-scanner preferentially) in routine care
- •Ability and willingness to follow scheduled visits with requested biological samples
- •Exclusion Criteria
- •- Patients previously treated with intravenous biphosphonate
排除标准
- 未提供
研究组 & 干预措施
intravenous biphosphonate
Patients treated with intravenous bisphosphonate until 12 months in routine care
干预措施: Blood and urine collection (Biological)
结局指标
主要结局
Changes in bone turnover markers
时间窗: Baseline, then every 2 months in 12 months
bone turnover markers include: C-terminal telopeptides of type I collagene (CTX) in serum, amino-terminal telopeptide of type 1 collagen (NTX) in urine, Dickkopf-1 (DKK-1) and Sclerostin (SOST) in plasma
次要结局
- time to maximum variation of bone turnover markers(Baseline, then every 2 months in 12 months)
- Doses of intravenous bisphosphonate(Up to 12 months)
- Rate of intravenous bisphosphonate(Up to 12 months)
- Number of adverse events likely to be related to bisphosphonate(Up to 12 months)
- evolution of bone lesions by imaging(Up to 12 months)
- Number of new bone events(Up to 12 months)
- Changes in Monoclonal protein(Baseline, then every 2 months in 12 months)