The Effect of Daily Whole-Body Vibration on Tibial Trabecular Bone Mineral Density in Osteopenic Postmenopausal Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 2
- 主要终点
- Trabecul volumetric bone mineral density (BMD) of the lower tibia (using peripheral quantitative computed tomography; pQCT))
研究概览
简要总结
This study will examine whether whole-body vibration slows down bone loss in healthy postmenopausal women with osteopenia. Whole-body vibration is a promising novel therapy that involves standing on a platform which produces extremely small and fast up-and-down movements. Some but not all research studies have found that whole-body vibration slowed down bone loss in postmenopausal women. One of the reasons why different studies found different results may be because they used various speeds of vibration. This study looks at how different speeds of whole-body vibration influence bone mineral density differently in postmenopausal women who have osteopenia. Two hundred postmenopausal women will take part in this 12-month study. Women will be randomly assigned into three groups (67 women per group) and these groups will be compared. Group 1 will receive very fast whole-body vibration, Group 2 will receive fast whole-body vibration, and Group 3 will not receive whole-body vibration. We will look at various bone mineral density and bone quality measurements, obtained with three different types of technologies, at the beginning of the study and at 12 months of follow-up. The hypothesis of this study is that the in comparison to Group 3 (no vibration), Groups 1 and 2 will experience reduced bone loss over 12 months, and that the greatest reduction in bone loss will be experienced by Group 1. The results of this study will help us determine whether whole-body vibration at different speeds produces variable effects on bone, hence explaining the inconsistency of the results obtained in previous studies.
详细描述
BACKGROUND:
Recent animal studies have shown that whole-body vibration increases bone mineral density. The effect of whole-body vibration on bone has been examined in only six small human studies with inconsistent results. Two of these studies have shown whole-body vibration reduces bone loss after menopause. Studies that used higher speed whole-body vibration may have produced greater reductions in bone loss.
OBJECTIVE AND HYPOTHESIS:
The objective of this study is to examine the effects of two whole-body vibration speeds trabecular BMD in the lower leg in osteopenic postmenopausal women. Two hundred postmenopausal women will take part in this 12-month study. Women will be randomly assigned into three groups (67 women per group) and these groups will be compared. Group 1 will receive very fast (90 Hz) whole-body vibration, Group 2 will receive fast (30 Hz) whole-body vibration, and Group 3 will not receive whole-body vibration. The hypothesis of this study is that the in comparison to Group 3 (no vibration), Groups 1 (very fast vibration, 90 Hz) and 2 (fast vibration, 30 Hz) will experience reduced bone loss over 12 months, and that the greatest reduction in bone loss will be experienced by Group 1.
METHODOLOGY:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •osteopenic
- •postmenopausal
排除标准
- •use of HRT in the past 12 months
- •use of raloxifene or parathyroid hormone in the past 6 months
- •use of bisphosphonates or fluoride in the past 3 months or ever taken for more than 3 months
- •current use of calcitonin
- •use of other medications that may indirectly affect bone metabolism
- •presence of metabolic bone disease or diseases that indirectly affect bone metabolism
- •occurrence of fragility fracture over 40 years of age
- •presence of unhealed non-fragility fracture (i.e., occurring less then 6 months ago)
- •having body mass ≤28 kg and ≥90 kg
- •having knee or hip joint replacements and spine implants
- •having poor balance (assessed by Timed-Up-and-Go)
- •presence of other medical risks for the study
- •inability to stand erect daily for 20 minutes
- •planned vacation or other activities that would prevent one from using the platform for ≥1 month
结局指标
主要结局
Trabecul volumetric bone mineral density (BMD) of the lower tibia (using peripheral quantitative computed tomography; pQCT))
时间窗: Baseline and 12 months
次要结局
- Total BMD of the lower tibia (using pQCT)(Baseline and 12 months)
- BMD lumbar spine (using DXA)(Baseline and 12 months)
- Trabecular thickness, separation, and number of the lower tibia (using pQCT)(Baseline and 12 months)
- Total BMD of the distal radius (using pQCT)(Baseline and 12 months)
- BMD at the femoral neck (using DXA)(Baseline and 12 months)
- BMD at the calcaneus (using quantitative ultrasound; QUS)(Baseline and 12 months)
- Speed of sound and broadband ultrasound attenuation at the calcaneus (QUS)(Baseline and 12 months)
- Cortical BMD and cortical thickness of the lower tibia (using pQCT)(Baseline and 12 months)
- Trabecular BMD and thickness, separation, and number of the distal radius (using pQCT)(Baseline and 12 months)
- Cortical BMD and cortical thickness of the distal radius (using pQCT)(Baseline and 12 months)
- BMD at the total hip (using dual x-ray absorptiometry; DXA)(Baseline and 12 months)