Effect of PTH Combined With Weight-Bearing on Bone Density and Bone Architecture in People With Spinal Cord Injury
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- BMD at Left Total Hip
研究概览
简要总结
Individuals with spinal cord injury sustain significant loss of bone mass in their lower extremities (20-40% or more). This study evaluates the ability of PTH and weight-bearing, two interventions that build bone, to increase bone mass in this population.
详细描述
This pilot project aims to evaluate PTH with weight-bearing in a group of individuals with chronic SCI and loss of bone mass in their lower extremities. A convenience sample of 12 people with SCI will be enrolled into a 6 month study assessing the effects of a weight-bearing regime plus daily PTH (Forteo 20ug sc) on BMD and bone markers. Subjects will be evaluated at 3 and 6 months after initiating treatment with measurement of bone density as well as bone markers of formation and resorption. An optional extension to 12 months will be offered to all subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •Complete SCI - total loss of motor function below level of lesion
- •Capable of positioning to have DEXA performed
- •Capable of undertaking the weight-bearing exercise regime
- •Capable of reading and understanding informed consent document
- •Able to self-administer PTH or have someone in the family who can do so
- •T score <-2.5 or Z score <-1.5 on evaluation of total hip BMD
- •No known endocrinopathies
- •Normal TSH levels
- •Normal 25-OH vitamin D levels
- •Normal calcium levels
- •Normal renal function (creatinine <2.0mg/dl)
- •Able to return for all follow-up visits
排除标准
- •Surgical or other intervention resulting in metal or anatomy precluding obtaining DEXA and/or MRI measurements
- •Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study
- •History of malignancy
- •History of radiation therapy
- •Unable to self-administer PTH or have it administered
- •Elevated liver function tests >2x normal
- •For males, significantly abnormal free testosterone levels
- •Currently being prescribed anti-convulsants
- •Currently being prescribed glucocorticoids, other than inhaled glucocorticoids
- •Currently being prescribed any bone-active agents, including any bisphosphonate, raloxifene, hormone therapy (estrogen and estrogen/progestin), calcitonin or strontium-containing compounds.
- •No previous history of bisphosphonate use
- •No previous use of other bone-specific agents during past 2 years
研究组 & 干预措施
PTH/Weight-Bearing
干预措施: teriparatide (Drug)
PTH/Weight-Bearing
干预措施: weight-bearing (Other)
结局指标
主要结局
BMD at Left Total Hip
时间窗: Baseline to 6 months
Bone mineral density (gm/cm2) of the total hip region of interest on the left
次要结局
- P1NP(Baseline to 6 months)
研究者
Thomas J. Schnitzer
professor
Northwestern University