The Role of Myokines in Postmenopausal Osteoporosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- follistatin
研究概览
简要总结
Circulating levels of several myokines will be measured in serum samples obtained from women in various categories of bone density and according to the presence of fracture or not as well as before and after treatment with teriparatide and denosumab
详细描述
Serum samples for the measurement of several myokines will be obtained from: 1) equal groups of premenopausal women with normal BMD, postmenopausal women with normal BMD, postmenopausal women with osteopenia, and postmenopausal women with osteoporosis; 2) women with hip fracture compared with controls (women subjected to surgery due to knee osteoathritis); 3) women with osteoporosis treated with teriparatide or denosumab for 12 months
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Substudy 1:
- •adult women
- •Substudy 2:
- •postmenopausal women with an incident hip fracture
- •Substudy 3:
- •postmenopausal women with osteoporosis
排除标准
- •secondary osteoporosis
- •any disease that could affect muscle and/or bone metabolism
- •any medication that could affect muscle and/or bone metabolism
研究组 & 干预措施
teriparatide group
postmenopausal women with osteoporosis who will be treated with teriparatide (Forsteo) 1 injection of 20mcg subcutaneously daily for 12 months
干预措施: Teriparatide (Drug)
denosumab group
postmenopausal women with osteoporosis who will be treated with denosumab (Prolia) 1 injection of 60mg subcutaneously every 6 months for 12 months
干预措施: Denosumab (Drug)
结局指标
主要结局
follistatin
时间窗: 0,3,12 months
circulating levels of myokine follistatin at baseline and their changes at 3 and 12 months with treatment
次要结局
- activin-A(0,3,12 months)
- FSTL3(0,3,12 months)
- irisin(0,3,12 months)
- activin-B(0,3,12 months)
研究者
Athanasios D. Anastasilakis
Principal Investigator
424 General Military Hospital