Effect of PTH Analog on Union Rates of Type II Odontoid Fractures in Older Adults
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Fracture Union
研究概览
简要总结
This is a prospective cohort study with a historical control group involving patients >=50 years-old with an acute (<3 weeks) Anderson & D'Alonzo type II dens fractures identified on cervical spine CT scan. This will be a pilot efficacy trial to compare treatment of odontoid fractures with 8 weeks of treatment with a parathyroid hormone analog (PTH) analog (abaloparatide) + hard collar immobilization in comparison to historical treatment with hard collar immobilization alone.
详细描述
Treatment subjects:
Patients will be identified and recruited when presenting with acute fracture to our medical center. Under routine care at our center, all cervical spine fractures are evaluated, either in person or via tele-consult for remote sites, by a fellowship trained Orthopedic or Neurosurgical Spine surgeon at the time of injury/hospitalization. If deemed amenable to non-operative treatment, that patient is then referred to the spine fracture clinic for serial clinical and radiographic follow-up.
The study will be introduced to the patient by a PI-delegated provider from the study team either during hospitalization or at their first visit to the spine fracture clinic - typically within 2 weeks of injury. Informed consent for this study may thus be obtained at one of two locations: (1) A majority (~75%) of these patients are admitted to the hospital; these patients will be introduced to the study by a PI-delegated provider who is key personnel on the study team, and may be consented while in the hospital. (2) Other patients may be identified and recruited from our Orthopedic Spine Fracture clinic, which is the referral repository for all non-operative spine fractures within our health system.
Patients with acute Anderson & D'Alonzo type II dens fractures, +/- C1 ring injury, identified on cervical CT scan, and recommended for non-operative treatment will be recruited for enrollment in the study. Acuity of the fracture will be determined by radiographic appearance, pain, and mechanism. Type II fractures are defined as involving the area of the dens between the inferior aspect of the anterior C1 ring and not extending into the superior articular facets of C2.
If a patient consents to participation in the study, baseline labs will be drawn. The study team's endocrinologist will review labs and confirm eligibility for the study. Lab values obtained during the screening process could exclude patients include an elevated PTH or hypercalcemia. Given the medical complexity, there will not be hard cutoff values for the labs but rather eligibility to participate will be left to the clinical judgement of our endocrinology investigator (fellowship-trained endocrinologist who is key personnel on the study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Primary outcome will be measured from CT by a radiologist blinded to whether the patient was part of the control or treatment group.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 years or older at time of consent [treatment subjects] or age 50 years or older at time of fracture (historical control subjects)
- •Anderson and D'Alonzo type II dens fracture identified on cervical spine CT, with or without a C1 ring injury. Type II dens fractures are defined as involving the area of the dens between the inferior aspect of the anterior C1 ring and not extending into the superior articular facets of C2 [all subjects]
- •Fracture is deemed amenable to non-operative treatment by treating fellowship trained spine surgeon [treatment subjects only]
- •Fracture occurred within the 3 weeks before consent [treatment subjects only]
- •Report of >=12 months of amenorrhea within the last year if the patient is female treatment subjects only]
- •Fracture injury occurred within 10 years before consent [historical control subjects only]
- •The patient completed 12 (+/-1) weeks of hard collar immobilization [historical control subjects only]
排除标准
- •Personal history of radiation therapy or accidental environmental exposure [treatment subjects only]
- •Personal history of osteosarcoma [treatment subjects only]
- •Personal history of Paget's disease [treatment subjects only]
- •Personal history of bone metastases or skeletal malignancy [treatment subjects only]
- •Hereditary disorders predisposing to osteosarcoma [treatment subjects only]
- •Prior teriparatide or abaloparatide use [treatment subjects only]
- •Any history of prior teriparatide or abaloparatide use [historical control subjects only]
- •Use of denosumab within the past year [all subjects]
- •Psychological impairment that precludes following hard collar immobilization recommendations [treatment subjects only]
- •Ineligible based on history of active or recurrent kidney stones, Comprehensive Metabolic Panel, PTH, Phos results to be determined on a case-by-case basis by an endocrinologist on the study team [treatment subjects only]
研究组 & 干预措施
Treatment group
Daily self-administered injection of 80 mcg abaloparatide (8 weeks) + hard collar immobilization (12 weeks)
干预措施: Abaloparatide (Drug)
Treatment group
Daily self-administered injection of 80 mcg abaloparatide (8 weeks) + hard collar immobilization (12 weeks)
干预措施: Hard collar immobilization (Device)
Historical control group
Patients who received only 12 weeks of hard collar immobilization
干预措施: Hard collar immobilization (Device)
结局指标
主要结局
Fracture Union
时间窗: 3 months after injury
% of bridging bone on cervical CT scan
次要结局
- Fracture Characteristics: Angulation(3 months after injury)
- Fracture Characteristics: Displacement(3 months after injury)
- Motion(3 months after injury)
- Neck Disability Index(3 months after injury)
- Visual Analog Scale (VAS) of Neck Pain(3 months after injury)
研究者
David Lunardini
Orthopedic Spine Surgeon
University of Vermont