PTH Analog Type II Odontoid Fracture

What Was Tested

The trial (phase 2) is built around Abaloparatide.

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.

It had two arms (groups): Treatment group (experimental) and Historical control group (active comparator).

Patients who received only 12 weeks of hard collar immobilization.

The registry classes the interventions as device and drug.

More on the Plan

Treatment subjects: Patients will be identified and recruited when presenting with acute fracture to their medical center.

Under routine care at their center, all cervical spine fractures are evaluated, either in person or via tele-consult for remote sites, by a fellowship trained Orthopedic or Neurosurgical Spine surgeon at the time of injury/hospitalization.

If deemed amenable to non-operative treatment, that patient is then referred to the spine fracture clinic for serial clinical and radiographic follow-up.

The study will be introduced to the patient by a PI-delegated provider from the study team either during hospitalization or at their first visit to the spine fracture clinic - typically within 2 weeks of injury.

Who Took Part

The registry lists 22 actual participants took part.

It was open to people of any sex aged from 50 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 50 years or older at time of consent \[treatment subjects\] or age 50 years or older at time of fracture (historical control 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 full record lists 7 inclusion and 10 exclusion criteria; among the exclusions: 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 \[treatment subjects only\].

How the Study Was Run

It was run as a non-randomized, single-group and single-blind study.

Only one side, usually the participants, was kept unaware of whether Abaloparatide was given.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: outcomes assessor.

It started in 2022-05-18 with completion listed for 2023-08-14.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Fracture Union (time frame: 3 months after injury).

It also tracked 5 secondary outcomes, for example Fracture Characteristics: Angulation, Fracture Characteristics: Displacement, Motion, Neck Disability Index and Visual Analog Scale (VAS) of Neck Pain.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Abaloparatide in 22 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Abaloparatide compound page, all human trials.