NCT01173081Unknown4 期
The Use of Teriparatide as an Adjunctive Therapy for the Treatment of Jones Fractures
Ohio Orthopedic Center of Excellence1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2010年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Fracture healing
研究概览
简要总结
This randomized, placebo-controlled study will evaluate the effectiveness of the adjunctive use of teriparatide for the healing of Jones fractures.
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
- Double (Participant, Investigator)
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 who are at least 18 years of age and who have closed epiphyses.
- •Patients of both genders and all races.
- •Patients with Jones fractures of the fifth metatarsal less than 2 weeks prior to presenting for clinical evaluation.
- •Patients with a history of an acute injury and an acute Jones fracture defined by Torg et al as a fracture line with sharp margins without widening, absence of intramedullary sclerosis, and minimal or no cortical hypertrophy or evidence of periosteal changes due to chronic stress.
- •Patients with either no prodromal symptoms or prodromal symptoms present less than 2 weeks.
- •Patients with a baseline visual analog scale (VAS) pain score ≤ 20 (100mm scale) for the fifth metatarsal, with the foot at rest and not bearing weight.
- •Patients who are in good general health and who have physical examinations that either are within normal limits or are clinically non-significant as determined by the investigator.
- •Patients with laboratory evaluations that either are within normal limits or are clinically non-significant as determined by the investigator.
- •Patients who have voluntarily signed informed consent forms, including HIPAA Authorization.
排除标准
- •Patients who are younger than 18 years of age or patients who are 18 years of age or older with open epiphyses.
- •Patients with Jones fractures of the fifth metatarsal greater than 2 weeks prior to presenting for clinical evaluation.
- •Patients with tuberosity avulsion fractures or fifth metatarsal shaft fractures.
- •Patients with prior fifth metatarsal fracture(s).
- •Patients with prodromal symptoms present for more than 2 weeks.
- •Patients with a nonunion or delayed union as defined by the radiographic criteria described by Torg et al.
- •Patients who are allergic to any of the individual active ingredients in teriparatide or related compounds.
- •Patients with chronic rheumatologic disease, ankylosing spondylitis or other inflammatory arthropathy.
- •Patients with associated injuries considered by the investigator as to likely interfere with evaluation of the study drug.
- •Patients with a present condition or history of any clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematologic, endocrine, neurologic, psychiatric, connective tissue, respiratory or other medical disorders.
- •Patients with Worker's Compensation claim(s) under dispute or mediation.
- •Patients with history of drug or alcohol abuse.
- •Patients who are pregnant or lactating.
- •Patients who are considered by the investigator for any reason to be an unsuitable candidate for receipt of the study drug.
- •Patients who are unwilling or unable to follow the follow-up evaluation schedules.
- •Patients who refuse to voluntarily sign the informed consent form.
研究组 & 干预措施
Teriparatide
Experimental
Patients randomized into this group will inject 20mcg of teriparatide once daily for 16 weeks or until the study endpoint is achieved. Additionally, patients will take oral calcium (1,000mg) and vitamin D3 (1,000 IU) supplements daily.
干预措施: Teriparatide (Drug)
Placebo Control
Placebo Comparator
Patients randomized into this group will inject a matching dose of placebo once daily for 16 weeks or until the study endpoint is achieved. Additionally, patients will take oral calcium (1,000mg) and vitamin D3 (1,000 IU) supplements daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Fracture healing
时间窗: weeks 4 through 24 after start of treatment
次要结局
- Pain(weeks 4 through 24 after start of treatment)
- Range of Motion(weeks 4 through 24 after start of treatment)
- Function(weeks 4 through 24 after start of treatment)
- Return to Activity(weeks 4 through 24 after start of treatment)
研究者
研究点 (1)
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