A Prospective Study of Human Bone Adaptation Using a Novel in Vivo Loading Model
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 主要终点
- Change in UD iBMC
研究概览
简要总结
The purpose of this study is to understand how different types of mechanical forces can influence bone adaptation (and make bones stronger, potentially). Forces acting on bones cause mechanical strain. In small animals, strain magnitude and rate have been shown to stimulate bone adaptation. This study is designed to test the degree to which strain magnitude and rate govern bone adaptation in healthy adult women.
详细描述
The study consists of three Aims:
Aim 1: compare the effect on bone structure of mechanical signals with low strain magnitude, high strain magnitude, and control groups over a 12-month prospective period.
Aim 2. Compare the effect on bone structure of mechanical signals with low strain rate, high strain rate, and control groups over a 12-month prospective period.
Aim 3: Examine the effect of withdrawing mechanical signals, by measuring bone structure during the 12 months after the intervention is withdrawn.
The intervention is a voluntary forearm compression task, consisting of leaning onto the palm of the hand to produce a target force.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
all data were blinded for analysis
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 21-40
- •Body Mass Index [18-29]
- •9-14 menstrual cycles/year
- •Dual energy X-ray Absorptiometry total radius bone mineral density (BMD) T-score [-2.5-+1]
- •Free of endocrinopathies
- •No known thyroid, vitamin D, or calcium abnormalities
排除标准
- •Fracture to wrist <5 years ago
- •Wrist Arthritis
- •Injury to the non-dominant elbow or shoulder <5 years ago
- •Severe disabling conditions
- •Cancer <5 years ago
- •Metabolic bone disease
- •Androgen, estrogen, progesterone, calcitonin, Selective Estrogen Receptor Modulators, Parathyroid hormone, gonadotropin-releasing hormone or analogs used <6 months ago
- •Corticosteroids <3 months ago
- •Bisphosphonates or fluoride <3 years ago
- •Cardiovascular/pulmonary disease
- •Uncontrolled hypertension
- •Regular Tobacco use
- •Marijuana use >1 time/week
- •Alcohol >4 drinks/day
- •Pregnancy or lactation <2 years ago
- •Plan to become pregnant or donate eggs within 1 year
- •Depot medroxyprogesterone acetate contraceptive <6 months ago
- •Current participation in upper extremity loading sports (gymnastics, tennis, softball, hockey) >2 times/month
- •Low calcium intake (avoiding dairy products without taking calcium supplement)
研究组 & 干预措施
Low Magnitude
voluntary forearm compression by leaning onto the palm of the hand with low target strain
干预措施: voluntary forearm loading task (Other)
High Magnitude
voluntary forearm compression by leaning onto the palm of the hand with high target strain
干预措施: voluntary forearm loading task (Other)
Low Rate
voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly")
干预措施: voluntary forearm loading task (Other)
High Rate
voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump")
干预措施: voluntary forearm loading task (Other)
Control
observation only
结局指标
主要结局
Change in UD iBMC
时间窗: baseline and 12 months
12-month change in ultra-distal integral bone mineral content, measured with quantitative computed tomography (QCT)
次要结局
- Change in UD tBMD(baseline and 12 months)
- Change in UD iBV(baseline and 12 months)
- Change in UD tBV(baseline and 12 months)
- Change in UD cBV(baseline and 12 months)
- Change in UD ecBMC(baseline and 12 months)
- Change in UD cBMC(baseline and 12 months)
- Change in UD tBMC(baseline and 12 months)
- Change in UD iBMD(baseline and 12 months)
- Change in UD cBMD(baseline and 12 months)
- Change in UD ecBMD(baseline and 12 months)
- Change in UD ecBV(baseline and 12 months)
- Change in Trabecular BV/TV(measurements repeated at 0, 3, 6, 9, and 12 months from enrollment)
- Change in Cortical Thickness(measurements repeated at 0, 3, 6, 9, 12, 18, and 24 months from enrollment)