PTH Analog Type II Odontoid Fracture

NCT04760782 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: STUDY00001025
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dens; Fracture; Odontoid; Non-union; Abaloparatide; Tymlos; C2

Outcome Measures

Primary Outcomes (1)

• Fracture Union

  % of bridging bone on cervical CT scan

  3 months after injury

Secondary Outcomes (5)

• Fracture Characteristics: Angulation

  3 months after injury

• Fracture Characteristics: Displacement

  3 months after injury

• Motion

  3 months after injury

• Neck Disability Index

  3 months after injury

• Visual Analog Scale (VAS) of Neck Pain

  3 months after injury

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Drug: Abaloparatide; Device: Hard collar immobilization

Historical control group

ACTIVE COMPARATOR

Patients who received only 12 weeks of hard collar immobilization

Device: Hard collar immobilization

Interventions

Abaloparatide DRUG

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

Also known as: Tymlos

Treatment group

Hard collar immobilization DEVICE

Hard collar immobilization of the cervical spine for 12 weeks

Historical control group; Treatment group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[historical control subjects only\]

You may not qualify if:

• 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 \[treatment subjects only\]

Sponsors & Collaborators

• David Lunardini: lead
• University of Vermont: collaborator

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Fractures, Bone

Interventions

abaloparatide

Condition Hierarchy (Ancestors)

Wounds and Injuries

Limitations and Caveats

Early termination due to recruitment barriers and slow recruitment rate. Insufficient statistical power for analyses with data collected before study termination.

Results Point of Contact

• Title: Dr. David Lunardini
• Organization: University of Vermont

david.lunardini@uvmhealth.org

(802) 847-2663

Study Officials

• David Lunardini, MD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Primary outcome will be measured from CT by a radiologist blinded to whether the patient was part of the control or treatment group.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Orthopedic Spine Surgeon

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 18, 2021
• Study Start: May 18, 2022
• Primary Completion: August 14, 2023
• Study Completion: August 14, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)