MicroRNAs Levels in Women With Postmenopausal Osteoporosis Under Antiresorptive or Osteoanabolic Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- detection of microRNA concentration in serum
研究概览
简要总结
The aim of this study is the quantitative determination of bone-specific microRNAs in the serum of postmenopausal women with osteoporosis during antiresorptive or osteoanabolic therapy.
详细描述
Primarily the influence of the therapeutic treatment on the microRNA concentration in the serum (treatment-response) and the relation between microRNA serum levels and changes of the bone mineral density will be investigated.
These data will help to examine the use of microRNAs as novel diagnostic biomarkers for the diagnosis of osteoporosis and targeted therapeutic treatment of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal women
- •Age 60-80 years
- •T-score according to DXA: <-2.5
- •indication for osteoporosis therapy according to international guidelines
排除标准
- •Diabetes mellitus type 1
- •renal insufficiency III-V °
- •Cirrhosis hepatis (Child B or higher)
- •Chronic alcohol abuse
- •rheumatic disease (RA, SpA, SLE)
- •Malignancies (<5 years)
- •Eating Disorder (anorexia nervosa, bulimia)
- •bone-specific pretreatment (DMAB, TPTD, strontium ranelate, SERMs) Bisphosphonate treatment is allowed
研究组 & 干预措施
Group 1 - DMAB
postmenopausal women without type 2 diabetes mellitus treated with denosumab
干预措施: Prolia, 60 Mg/mL Subcutaneous Solution (Drug)
Group 2 - TPTD
postmenopausal women with type 2 Diabetes mellitus treated with teriparatide
干预措施: Teriparatide (Drug)
Group 3 - DMAB
postmenopausal women with type 2 diabetes mellitus treated with denosumab
干预措施: Prolia, 60 Mg/mL Subcutaneous Solution (Drug)
Group 4 - TPTD
postmenopausal women without type 2 diabetes mellitus treated with teriparatid
干预措施: Teriparatide (Drug)
结局指标
主要结局
detection of microRNA concentration in serum
时间窗: 24 months
influence of antiresorptive or osteoanabolic Treatment on microRNA levels in postmenopausal women with osteoporosis
次要结局
- microRNAs and changes in bone metabolism under treatment(24 months)
研究者
Dr. Christian Muschitz
OA Priv. Doz. Dr. Christian Muschitz
Medical University of Vienna