PTH Analog Type II Odontoid Fracture

• Status: Not yet recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

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 PTH analog (abaloparatide) + hard collar immobilization in comparison to historical treatment with hard collar immobilization alone.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: David Lunardini
• Collaborator: University of Vermont
• Treatments: Abaloparatide

Criteria

Inclusion Criteria:

• Age 50 years or older at time of consent [all 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 having < 25% of unilateral C2 superior articular process involvement; and < 2 mm extension caudally into the body of the dens [all subjects]

• Fracture is deemed amendable 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 3 years before consent [historical control subjects only]

• The patient completed 12 weeks of hard collar immobilization [historical control subjects only]

• The patient is able to return to clinic for study imaging [historical control subjects only]

Exclusion Criteria:

• Fracture has bilateral superior articular facet involvement [treatment subjects only]

• 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 abaloperatide use [treatment subjects only]

• Any history of prior teriparatide or alaparatide 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]

• Ineligibility based on history of active or recurrent kidney stones, CMP, PTH, Phos results to be determined on a case-by-case basis by an endocrinologist on the study team [treatment subjects only]