The Use of Oxandrolone to Improve Function in Persons With Chronic Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Part-A: lean body mass, upper extremity muscle strength. Measures are made at baseline, 12-weeks (end of intervention), and at 24-weeks.
研究概览
简要总结
The purpose of this study is to determine the effect of oxandrolone on the function and quality of life of patients with chronic spinal cord injury.
详细描述
Spinal cord injury results in significant loss of muscle mass. Oxandrolone, a derivative of testosterone, is an anabolic steroid shown to promote gain in body weight and muscle mass after trauma, severe illness, surgery, burns, and stress. To date there are no studies that have evaluated the effect of oxandrolone in persons with chronic spinal cord injury. This study will assess the effect of oxandrolone on strength, metabolic rate, lean body mass, pulmonary function, and ambulation in persons with chronic SCI. This study has the potential to yield valuable information concerning the use of oxandrolone after SCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with a traumatic injury to spinal cord
- •Motor complete injury at level of C5 to T12
- •Date of injury at least one year prior to enrollment
- •Sufficient upper body strength to participate in a 12-week resistance training program with accommodation for disability in hand strength and/or grasping
- •Lean body mass in lower extremities less than 90% of normal as determined by DEXA scan
- •Willingness to take study medication for 12 weeks twice a day by mouth
- •Diagnosed with a traumatic injury to the spinal cord
- •Motor incomplete injury at any level
- •Date of injury at least one year prior to enrollment
- •Lean body mass in lower extremities less than 90% of normal as determined by DEXA scan
- •Ability to stand independently with or without the aid of assistive device(s)
- •Willingness to take study medication for 12 weeks twice a day by mouth
排除标准
- •Active medical problems including:
- •Uncontrolled diabetes
- •Cardiovascular disease
- •Liver disease
- •Hypocalcaemia
- •Nephritic syndrome
- •Pressure ulcers of grade 3 or 4
- •Shoulder pathology
- •Pregnancy
结局指标
主要结局
Part-A: lean body mass, upper extremity muscle strength. Measures are made at baseline, 12-weeks (end of intervention), and at 24-weeks.
Part-B: respiratory function, efficency of ambulaton (speed and quality of gait). Measures are made at baseline,
12-weeks (end of intervention), and at 24-weeks.
次要结局
- Part-A: maximum VO2/respiratory function, functional status, safety, quality of life, community
- re-integration.
- Part-B: upper extremity strength, lean body mass, functional status, safety, quality of life, community