NCT03688282已完成不适用
Wearable Vibration Device to Prevent Bone Loss in Postmenopausal Women--Aim 2
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Percent Change in Blood-based Biomarker of Bone Loss
研究概览
简要总结
The wearable vibration device aims to consistently deliver vibrations directly to the hip and spine and allowing use during many everyday activities. We propose that demonstrating higher rates of compliance and consistent delivery of optimal force, with accelerometer feedback, will provide a superior alternative to whole body vibration and is plausibly more effective at preventing bone loss in postmenopausal women than vibration platforms in the home setting.
详细描述
The goal of this study is to demonstrate that postmenopausal women will tolerate our device, have high rates of compliance with the study protocol, receive consistently therapeutic levels of vibration and see significant effects on bone turnover based on plasma markers of bone anabolism and catabolism.
The anticipated outcomes from serum draws are an improvement in two bone turnover markers after a 30 minute treatment with the WVD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Last menstrual period at least one year prior and not more than eight years prior.
- •19 years of age and older.
- •BMD T-score at or above -2.49 at the total hip and L1-L4 spine skeletal sites as measured by DXA.
- •Ambulatory (can walk or stand without an assistive device for a minimum of 30 minutes).
- •Able to understand spoken and written English.
- •Capable and willing to follow all study-related procedures.
排除标准
- •BMD T-score at or below -2.5 at the total hip and L1-L4 spine skeletal sites as measured by DXA.
- •A 10-year probability of hip fracture of > 3% or major fracture of > 20% based on results of DXA using the FRAX tool (see attached).
- •Weight > 300 lbs.
- •Are currently taking or have taken bisphosphonates within the past 12 months, estrogen replacement therapy, or drugs affecting bone such as tamoxifen or aromatase inhibitors within the past 6 months.
- •Active cancer or cancer treatment.
- •Any change in exercise in the past 3 months.
- •Fractures or major surgery within the past 6 months.
- •Medical Implants (excluding dental implants).
- •Diagnosed with Paget's disease, heart disease, uncontrolled hypertension, renal disease, chronic fatigue syndrome, herniated disc, severe peripheral neuropathy, severe osteoarthritis.
- •Any bleeding disorder or treatment with a blood thinning medication within the last 2 years.
- •Hip circumference is greater than 42 inches
研究组 & 干预措施
Sham Wearable belt
Sham Comparator
Device will be worn but not turned on for 30 minutes.
干预措施: Sham, wearing belt (Device)
Wearable vibration belt (30)
Experimental
Device will be worn and turned on for 30 minute treatment.
干预措施: Wearable vibration belt (Device)
结局指标
主要结局
Percent Change in Blood-based Biomarker of Bone Loss
时间窗: Baseline and 30 minutes after completing the 30-minute treatment session
Percent change in NTX, a biomarker of bone loss activity measured in the blood. Percent change in NTX was determined from Baseline (pre-treatment) to 30-minutes post-treatment for the sham treatment and the active treatments. The difference in percent change was then compared between active and sham treatments.
次要结局
未报告次要终点
研究者
研究点 (1)
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