PTH Analog Type II Odontoid Fracture (NCT04760782) | Clinical Trial Compass
TerminatedPhase 2
PTH Analog Type II Odontoid Fracture
Stopped: Study terminated early due to low recruitment rate.
United States22 participantsStarted 2022-05-18
Plain-language 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 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.
Who can participate
Age range50 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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 hi…