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 range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fracture Union

Timeframe: 3 months after injury

Trial details

NCT IDNCT04760782

SponsorDavid Lunardini

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-14

Results submitted2024-06-17

View on ClinicalTrials.gov More Odontoid Fracture trials