Prevention of Bone Loss After Acute SCI by Zoledronic Acid: Durability, Effect on Bone Strength, and Use of Biomarkers to Guide Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Percent Change of Bone Mass Density (BMD) in the Femoral Neck
研究概览
简要总结
The overall objective of this study is to define an effective therapeutic approach, using currently available medication, to prevent or mitigate the loss of bone mass and bone strength that occurs after acute spinal cord injury.
详细描述
This is a randomized, double-blind placebo-controlled study of zoledronic acid to evaluate its efficacy and safety over a 2 year period for the prevention of bone loss and maintenance of bone strength in individuals with recent onset SCI (see diagram below). Subjects will be randomized at the baseline visit to receive either zoledronic acid or placebo. At the end of the first year of the study, each treatment group will be re-randomized to either zoledronic acid or placebo to evaluate the durability of response to zoledronic acid and the utility of serum bone markers to guide therapeutic decision making. DXA imaging, CT imaging and bone markers will be obtained at baseline, 3 months, 6 months, 12 months, 18 months and 24 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In-patient at Rehabilitation Institute of Chicago (RIC) or an outpatient who was recently discharged from RIC
- •Males and females
- •Age >/=18 years
- •Medically stable in the opinion of subject's physiatrist
- •SCI at within 120 days inclusive at time of screening
- •SCI with inability to ambulate independently
- •ASIA Impairment Scale (AIS) A, B, or C, at time of study entry
- •Capable of positioning to have DXA performed
- •Able to tolerate acetaminophen
- •No known endocrinopathies (diabetes type 1 or 2 can be included)
- •Normal TSH levels
- •Normal 25-OH vitamin D levels (>/= 20 ng/ml) at baseline (subjects may be repleted)
- •Normal calcium levels
- •Normal renal function (creatinine <2.0 mg/dl)
- •Well hydrated with adequate intake of liquids
- •Able to return for all follow-up visits
- •Capable of reading and understanding informed consent document
- •Males and females of childbearing potential must be willing and able to use double barrier method of contraception for 2 months after having received study drug
排除标准
- •Have Paget's disease of the bone
- •Malignancy as a cause of acute SCI
- •Have unexplained high levels of alkaline phosphatase in blood
- •Any active gastrointestinal condition that results in malabsorption
- •Poor dental hygiene or requirement for invasive dental procedure within two months prior to enrollment
- •History of bone metastasis and skeletal malignancies
- •History 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
- •Elevated liver function tests >2x normal
- •Currently being prescribed anti-convulsants at a dose or frequency that is determined to interfere with bone metabolism as determined by the investigator
- •Currently being prescribed glucocorticoids, other than inhaled glucocorticoids
- •Current or recent use any bone-active agents, including any bisphosphonate, raloxifene, hormone therapy (estrogen and estrogen/progestin), calcitonin or strontium-containing compounds within 60 days of screening.
- •Pregnant, planning to become pregnant, or lactating
研究组 & 干预措施
Zol
Intravenous infusion of zoledronic acid (zol) 5 mg at baseline.
干预措施: Zoledronic acid (Drug)
Placebo
Intravenous infusion of placebo at baseline.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change of Bone Mass Density (BMD) in the Femoral Neck
时间窗: 0-12 months
Percent change of bone mass density (BMD) in the femoral neck (as measured by DXA)
Percent Change in Bone Mass Density (BMD) in the Hip
时间窗: 0-12 months
Percent change of bone mass density (BMD) in the total hip (as measured by DXA)
次要结局
- Percent Change in the Epiphyseal Integral Bone Mass Content (iBMC) of the Femur(0-12 months)
- Percent Change in the Metaphyseal Integral Bone Mass Content (iBMC) of the Femur(0-12 months)
研究者
Thomas J. Schnitzer
Professor
Northwestern University