Status:
TERMINATED
PTH Analog Type II Odontoid Fracture
Lead Sponsor:
David Lunardini
Collaborating Sponsors:
University of Vermont
Conditions:
Odontoid Fracture
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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, ...
Eligibility Criteria
Inclusion
- 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 \[historical control subjects only\]
Exclusion
- 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 \[treatment subjects only\]
Key Trial Info
Start Date :
May 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2023
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04760782
Start Date
May 18 2022
End Date
August 14 2023
Last Update
September 19 2024
Active Locations (1)
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1
University of Vermont Medical Center
Burlington, Vermont, United States, 05401