Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Bone Mineral Density BMD of the Total Hip as Assessed by DXA.
研究概览
简要总结
Spinal cord injury (SCI) results in marked acute loss of bone. This study evaluates the effect of teriparatide (PTH) and the use of vibration as a form of mechanical stimulation on bone mass.
详细描述
The aim of this study is to evaluate PTH with vibration in a group of individuals with chronic SCI and loss of bone mass in their lower extremities. A convenience sample of 60 subjects with SCI will be enrolled into a 12 month study assessing the effects of PTH (20 ug/day) and vibration (10 min/day) individually or in combination on BMD and bone markers. Subjects will be evaluated at 3, 6, 9, and 12 months after initiating treatment with measurement of bone density as well as bone markers of formation and resorption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >21 years (must have closed epiphyses; PTH contraindicated if epiphyses open)
- •Both males and females
- •SCI with inability to ambulate independently
- •Capable of positioning to have DXA performed
- •Low bone mass at the total hip by DEXA (Z score < 1.5; T score < 2.5 or T score <-2.0 plus preexisting fragility fracture)
- •Capable of reading and understanding informed consent document
- •Able to self-administer teriparatide or have someone in the family who can do so
- •No known endocrinopathies
- •Normal TSH levels
- •Normal 25-OH vitamin D levels (> 30ng/ml)
- •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 DXA measurements (e.g., cardiac pacemakers, ferromagnetic implants or brain aneurysm clips).
- •Had had an allergic reaction to Teriparatide (FORTEO) or one of its ingredients.
- •Have Paget's disease of the bone
- •Have unexplained high levels of f alkaline phosphatase in blood
- •Any active Gastrointestinal condition that results in malabsorption
- •History of presence of alcoholism or drug abuse within the 2 years prior to study screening
- •Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study
- •History of malignancy. Patients having had basal cell carcinomas successfully removed will be allowed to enroll in the protocol.
- •History of radiation therapy
- •Unable to self-administer PTH or have it administered
- •Elevated liver function tests >2x normal
- •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. Bisphosphonate use will be allowed up the time of initiation of study medication but not during the dosing with study medication.
- •Previous history of PTH use
- •Pregnant, planning to become pregnant, or lactating
研究组 & 干预措施
Teriparatide
Teriparatide alone with sham vibration
干预措施: Teriparatide (Drug)
Vibration
Vibration alone with placebo-teriparatide
干预措施: vibration (Device)
Teriparatide and vibration
Teriparatide with vibration applied in conjuction
干预措施: Teriparatide (Drug)
Teriparatide and vibration
Teriparatide with vibration applied in conjuction
干预措施: vibration (Device)
结局指标
主要结局
Bone Mineral Density BMD of the Total Hip as Assessed by DXA.
时间窗: Baseline to 12 Months
The mean change in BMD of the total hip after 12 month of treatment
次要结局
- Bone Mineral Density (BMD) by DXA at the Lumbar Spine.(Baseline to 12 Months)
- Bone Mineral Density (BMD) by DXA at Femoral Neck(Baseline to 12 Months)
- Amino-terminal Propeptide of Type 1 Collagen(Baseline to 12 Months)
- C-terminal Telopeptide(Baseline to 12 Months)
- Bone-specific Alkaline Phosphatase(Baseline to 12 Months)
研究者
Thomas J. Schnitzer
professor
Northwestern University