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Trial · Interventional

TerminatedPhase 2Results postedRegistry data

PTH Analog Type II Odontoid Fracture

NCTNCT04760782 (opens ClinicalTrials.gov in a new tab)Other idSTUDY00001025
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 2
Enrollment
22 participants (actual)
Sponsor
David Lunardini · Other
Design
Not randomized · Single masking
Countries
1 country

United States

Start
18 May 2022
Primary completion
14 Aug 2023
Completion
14 Aug 2023
First posted
18 Feb 2021
Last update posted
19 Sept 2024
Conditions
Odontoid Fracture

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202220232024
  1. Ph 2

    PTH Analog Type II Odontoid Fracture

    NCT04760782

    18 May 2022 to 14 Aug 2023

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • AbaloparatideDrug
  • Hard collar immobilizationDevice

Arms2

  • Experimental

    Treatment group

    Daily self-administered injection of 80 mcg abaloparatide (8 weeks) + hard collar immobilization (12 weeks)

  • Active comparator

    Historical control group

    Patients who received only 12 weeks of hard collar immobilization

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Fracture Union

    Time frame · 3 months after injury

    Registry description

    % of bridging bone on cervical CT scan

Secondary outcomes(5)

  1. Fracture Characteristics: Angulation

    Time frame · 3 months after injury

    Registry description

    Angulation of the dens fracture fragment will be measured in degrees, using lines paralleling the posterior cortex of the proximal fracture fragment in relation to the posterior cortex of the distal C2 body.

  2. Fracture Characteristics: Displacement

    Time frame · 3 months after injury

    Registry description

    Fracture displacement will be measured in millimeters of translation between the posterior cortex of the fracture fragment and the posterior cortex of the body of the dens.

  3. Motion

    Time frame · 3 months after injury

    Registry description

    C1-2 motion on flexion/extension views, which will be determined by measuring the translational distance of the posterior aspect of the C1 ring in relation to the anterior margin of the body of the dens in both flexion and extension positions. The difference between these measurements (in millimeters) will be documented as the motion

  4. Neck Disability Index

    Time frame · 3 months after injury

    Registry description

    Patient-reported quality of life outcome. The Neck Disability Index provides a measurement (score from 0-50, converted to a percentage) of how neck pain is affecting their day to day life. Questions concern pain intensity, personal care, lifting, reading, headaches, ability to concentrate, work, driving, sleeping, recreation. A higher score/percentage represents increased difficulty with everyday life due to the patient's neck pain.

  5. Visual Analog Scale (VAS) of Neck Pain

    Time frame · 3 months after injury

    Registry description

    This will include a patient-reported numeric scale rating of neck pain from 0 to 10, with higher scores representing increased levels of pain.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· 3 months after injury

Fracture Union

GroupValue (percentage of total healing)
Treatment Group0
Historical Control Group3.6
Secondary and other outcome results(5)
Secondary outcomeMedian· 3 months after injury

Fracture Characteristics: Angulation

GroupValue (Degrees)
Treatment Group19.0
Historical Control Group36.6
Secondary outcomeMedian· 3 months after injury

Fracture Characteristics: Displacement

GroupValue (mm)
Treatment Group0
Historical Control Group1.7
Secondary outcomeMedian· 3 months after injury

Motion

GroupValue (mm)
Treatment Group2.9
Historical Control Group0
Secondary outcomeMedian· 3 months after injury

Neck Disability Index

GroupValue (percentage of 100 total points)
Treatment Group28
Historical Control Group6.5
Secondary outcomeMedian· 3 months after injury

Visual Analog Scale (VAS) of Neck Pain

GroupValue (score on a scale)
Treatment Group0
Historical Control Group0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Treatment GroupDaily self-administered injection of 80 mcg abaloparatide (8 weeks) + hard collar immobilization (12 weeks) Abaloparatide: Abaloparatide 80 mcg by subcutaneous, self-administered injection once per day (8 weeks) Hard collar immobilization: Hard collar immobilization of the cervical spine for 12 weeks1 / 51 / 50 / 5
Historical Control GroupPatients who received only 12 weeks of hard collar immobilization Hard collar immobilization: Hard collar immobilization of the cervical spine for 12 weeks0 / 20 / 20 / 2

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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 history of prior teriparatide or abaloparatide use \[historical control subjects only\] * Use of denosumab within the past year \[all subjects\] * Psychological impairment that precludes following hard collar immobilization recommendations \[treatment subjects only\] * Ineligible based on history of active or recurrent kidney stones, Comprehensive Metabolic Panel, PTH, Phos results to be determined on a case-by-case basis by an endocrinologist on the study team \[treatment subjects only\]

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