Use of Teriparatide to Accelerate Fracture Healing
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Healing of a Fracture From a Low Energy Fall
研究概览
简要总结
The purpose of this study is to compare the effect of the drug teriparatide to the effect of placebo on pelvic fracture healing.
详细描述
Teriparatide is a man-made form of a naturally occurring hormone called parathyroid. It increases bone density and bone strength to help prevent fractures and can be used to treat osteoporosis in people who have a high risk of bone fracture. The purpose of this study is to compare the effect of teriparatide to the effect of placebo on pelvic fracture healing.
This study will last 16 weeks. Participants will be randomly assigned to receive either teriparatide or placebo for the duration of the study. Participants will also be given calcium and vitamin D supplements to take daily throughout the study. At 4-week intervals, participants will undergo functional evaluations that will include the instrumented sit-to-stand test, the timed-up-and-go, and a gait velocity test. Participants will also undergo a DXA scan upon enrollment; undergo a CT evaluation upon enrollment and 16 weeks post-fracture; and complete specific pain, self-perceived function, mental status, and depression scales throughout the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females must be menopausal (no menses within the last 12 months)
- •Low energy fragility fractures of the pelvis, including anterior column, posterior column, inferior or superior rami, or sacrum
- •Maximum of 2 weeks post fracture
- •Mental status consistent with completing the study protocol
排除标准
- •Currently receiving any treatment for osteoporosis, including estrogen and estrogenic-like compounds
- •Received radiation treatment to any site at any time in the past
- •Received chemotherapy for cancer at any time in the past
- •Any active cancer
- •Surgical repair (or attempted repair) of the fracture site in the pelvis
- •Use of any bone-active medications
- •Use of anticonvulsant therapy
- •Use of immunosuppressants
- •Any renal, gastrointestinal, liver, or metabolic bone disease
- •Pregnancy
- •High calcium, parathyroid hormone, or alkaline phosphatase, as based on laboratory results
研究组 & 干预措施
Injection
30 participants will receive teriparatide (Forteo) injection pens.
干预措施: Teriparatide (Drug)
Placebo
30 participants will receive placebo injection pens.
干预措施: Placebo (Drug)
结局指标
主要结局
Healing of a Fracture From a Low Energy Fall
时间窗: Measured at 16 weeks
Callus formation at the fracture site as defined by a CT scan to determine healing (early/beginning callus formation) or healed (complete callus formation)
次要结局
未报告次要终点
研究者
Edward Puzas
Dr.
University of Rochester