Low Magnitude Mechanical Stimulation (LMMS) to Improve Bone Mineral Density (BMD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- Changes in volumetric trabecular BMD of the spine and hip by quantitative computed tomography (CT scan)
研究概览
简要总结
The purpose of this study is to determine if daily low magnitude, high frequency whole body vibration can improve bone density in seniors.
详细描述
The treatment options for osteoporosis, a major health complication in the aged population, are limited to pharmacologic interventions, the majority of which are antiresorptive. Preliminary data demonstrate that high frequency, low magnitude mechanical stimulation (LMMS) can preserve bone mineral density (BMD) by preventing bone resorption due to disuse and aging, and can stimulate new bone formation.
To confirm and extend these observations, this study is a three-year, double-blind, randomized, placebo-controlled clinical trial of LMMS in 200 elderly women and men (60 years of age and older). A clinical center located in Boston, MA has recruited participants from multiple independent living facilities in close geographic proximity. Participants meeting the inclusion/exclusion criteria have been randomized to either brief daily exposure to LMMS on a vibrating platform or a placebo platform over a three year period. All participants receive 1000 mg of elemental calcium and 800 IU of vitamin D per day.
This study will provide new and important information about the role of low magnitude high frequency mechanical stimulation on the skeleton.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women 60 years and over of all ethnic groups
- •Weight less than 250 pounds
- •Absence of terminal cancer or other illness necessitating hospice level services
- •Capable of following the protocol and of understanding and providing informed consent
- •Scoring less than 12 on the Short Blessed Test
排除标准
- •Immobilization of the axial or lower appendicular skeleton within the last year
- •Nonambulatory (ambulation with an assistive device will be permitted)
- •Malignancy other than cured thyroid cancer or skin cancer
- •Hip replacement or internal fixation, total knee replacement, or lower limb fracture within the past year, or bilateral hip replacement
- •Medications: glucocorticoids, suppressive doses of thyroid hormone as determined by screening TSH, anticonvulsant drugs (phenytoin, phenobarbital, carbamazepine), estrogen/testosterone replacement, selective estrogen receptor modulators (SERMs), PTH, or bisphosphonates more than 1 month in past year, calcitonin therapy within the preceding month, fluoride therapy at any time
- •Paget's disease of bone, rheumatoid arthritis or other connective tissue disorders requiring systemic treatment with disease modifying drugs, or a history of Cushing's syndrome
- •Fragility fracture within the past five years unless pharmacologic therapy not to be prescribed
结局指标
主要结局
Changes in volumetric trabecular BMD of the spine and hip by quantitative computed tomography (CT scan)
时间窗: 2 - 3 years
次要结局
- Changes in biochemical markers of bone formation (Procollagen type 1 N-terminal peptide and Bone Specific Alkaline Phosphatase) and resorption (C-terminal Telopeptide of type I collagen)(2 - 3 years)
- Changes in postural stability(2 - 3 years)
- Changes in isometric leg extension strength(2 - 3 years)
- Change in hip muscle area and density(2 - 3 years)
研究者
Douglas Kiel
Director Musculoskeletal Research Center
Hebrew SeniorLife