PTH and Vibration in OSteoporosis (PaVOS) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Changes in the BMD, Bone Mineral Density of hip and spine region (Hologic DXA machine)
研究概览
简要总结
Objective:
This is a randomized controlled trial (RCT) in osteoporosis patients randomized to standard parathyroid hormone (PTH) treatment alone or to standard PTH treatment and Whole-body vibration (WBV). PTH is an effective but expensive anabolic treatment for osteoporosis. WBV stimulates muscles and bones. A combined treatment might have synergistic or additive beneficial effects on bone, reducing fracture risk making treatment more effective and cost-effective. A beneficial effect on muscles and thereby falls risk of WBV may improve fracture risk even further.
If the results of this pilot study are promising then a strong case can be made for a large multi-centre RCT using strong endpoints including fractures and falls.
详细描述
Study Objectives
- To determine if WBV in addition to standard PTH treatment has a greater effect on bone mass in osteoporosis patients compared to standard PTH treatment alone.
- To determine if WBV in addition to standard PTH treatment has a greater effect on bone microarchitecture in osteoporosis patients compared to standard PTH treatment alone, as assessed by high resolution peripheral quantitative computed tomography (HR-pQCT).
- To determine if WBV in addition to standard PTH treatment has a greater effect on markers of bone formation and resorption in osteoporosis patients compared to standard PTH treatment alone.
- To study the effects of WBV on muscle function and balance in osteoporosis
- To assess the safety and adherence to WBV in osteoporotic patients
Study Design:
General Design This will be a multi-center randomized controlled trial (RCT) in osteoporosis patients being started on standard PTH treatment according to Danish Osteoporosis guidelines. Participants will be randomized to standard PTH treatment alone or to standard PTH treatment and WBV.
Statistical Plan:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women starting PTH treatment for osteoporosis according to Danish Osteoporosis guidelines
排除标准
- •Women currently taking oral glucocorticoids
- •Women unable to give informed consent
- •Women unable to stand for 2 minutes at a time on the vibration platform
- •Women who have contraindications to WBV (e.g. joint prosthesis, pacemakers)
研究组 & 干预措施
controlgroup
Teriparatide, 20 microgram/day. 24 months of treatment
干预措施: teriparatide (Drug)
studygroup 1
Teriparatide, 20 microgram/day. 24 months of treatment.
12 months of Whole-body vibration on vibration platforms.
干预措施: whole-body vibration (Other)
studygroup 1
Teriparatide, 20 microgram/day. 24 months of treatment.
12 months of Whole-body vibration on vibration platforms.
干预措施: teriparatide (Drug)
studygroup 2
Teriparatide, 20 microgram/day. 24 months of treatment.
24 months of Whole-body vibration on vibration platforms
干预措施: whole-body vibration (Other)
studygroup 2
Teriparatide, 20 microgram/day. 24 months of treatment.
24 months of Whole-body vibration on vibration platforms
干预措施: teriparatide (Drug)
结局指标
主要结局
Changes in the BMD, Bone Mineral Density of hip and spine region (Hologic DXA machine)
时间窗: at the time the participants start treatment and in an interval as close as possible to after 6, 12, 18, 24 months from baseline
DXA scan of hip and spine regions, BMD (g/cm\^2)
次要结局
- Changes in basic mobility(at the time the participants start treatment and in an interval as close as possible to after 3,6,12,18 and 24 months from baseline)
- Changes in The Falls Efficacy Scale International(at the time the participants start treatment and in an interval as close as possible to after 12, and 24 months from baseline)
- Changes in the Bone microarchitecture at the radius(at the time the participants start treatment and in an interval as close as possible to after 6, 12, 18 and 24 months from baseline)
- Changes in the Bone microarchitecture at the tibia(at the time the participants start treatment and in an interval as close as possible to after 6, 12, 18 and 24 months from baseline)
- changes in muscle mass(at the time the participants start treatment and in an interval as close as possible to after 12 and 24 months from baseline)
- Changes from baseline in the markers of bone resorption(at the time the participants start treatment and in an interval as close as possible to after 3, 6, 12, 18, 24 months from baseline)
- Changes from baseline in the markers of bone formation(at the time the participants start treatment and in an interval as close as possible to after 3, 6, 12, 18, 24 months from baseline)
- Changes in handgrip strength(at the time the participants start treatment and in an interval as close as possible to after 3,6,12,18 and 24 months from baseline)
- Changes in Balance(at the time the participants start treatment and in an interval as close as possible to after 3, 6 ,12, 18 and 24 months from baseline)
- Adherence to WBV(During 2 years from the start of the treatment)
- Changes in physical activity(at the time the participants start treatment and in an interval as close as possible to after 12, and 24 months from baseline)
- Changes in quality of life(at the time the participants start treatment and in an interval as close as possible to after 12, and 24 months from baseline)
- Changes in Muscle strength(at the time the participants start treatment and in an interval as close as possible to after 3,6,12,18 and 24 months from baseline)
研究者
Lars Matzen
MD, Clin. Ass. Professor
Odense University Hospital