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PTH Analog Type II Odontoid Fracture

NCT04760782 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-09-19

Study results available
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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.

Conditions

  • Odontoid Fracture

Interventions

DRUG

Abaloparatide

Abaloparatide 80 mcg by subcutaneous, self-administered injection once per day (8 weeks)

DEVICE

Hard collar immobilization

Hard collar immobilization of the cervical spine for 12 weeks

Sponsors & Collaborators

  • University of Vermont

    collaborator OTHER

  • David Lunardini

    lead OTHER

Principal Investigators

  • David Lunardini, MD · University of Vermont

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-18
Primary Completion
2023-08-14
Completion
2023-08-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04760782 on ClinicalTrials.gov