NCT05893069暂停4 期
Ability of Oral Oxandrolone to Aid in Rehabilitation and Outcomes of Multiligament Knee Reconstructions: A Double-Blind, Randomized Controlled Trial
George F. Hatch1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- body fat percentage
研究概览
简要总结
This study is about healing after a rmultiligament knee reconstruction procedure. We hope to learn if a biologic medication: Oxandrolone, a synthetic derivative of the human hormone Testosterone (the principal male sex hormone and an anabolic steroid), given for 12 weeks is effective in aiding in the healing process and restoring muscle mass.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Randomized
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
- •Patients with MRI proven multiligament knee injury scheduled to undergo multiligament knee reconstruction
排除标准
- •Patients with prior ipsilateral knee surgery
- •Untreated diabetes mellitus
- •Pituitary tumor
- •Rheumatoid Arthritis
- •Uncontrolled hypertension
- •Congestive Heart Failure
- •Myocardial Infarction within the past 6 months
- •End-stage renal disease
- •Liver enzymes two times the normal value
- •DVT within the past 6 months
- •Disorder of the coagulation system
- •Currently taking anticoagulation
- •Prior or current use of anabolic steroids
- •Chromosomal disorders
- •Prostate cancer
- •Breast cancer
- •Hypercalcemia
- •Patients with COPD not responsive to bronchodilators
- •Patients with known liver disease
- •Patients at risk for liver tumors
- •Severe hyperlipidemia
- •Patients taking medications that interfere with testosterone production or function, including but not limited to 5α-reductase inhibitors, acetaminophen (Tylenol, others), cholesterol lowering
研究组 & 干预措施
Treatment group
Experimental
Oxandrolone
干预措施: Oxandrolone (Drug)
Placebo Group
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
body fat percentage
时间窗: Change from baseline at 52 weeksf
measured by bioelectrical impedance analysis
lean body mass
时间窗: Change from baseline at 52 weeks
measured by bioelectrical impedance analysis
次要结局
未报告次要终点
研究者
George F. Hatch
Associate Professor
University of Southern California
研究点 (1)
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