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PTH Analog
Hormone Analog + Immobilization for Neck Fractures
Phase 2
Recruiting
Led By David Lunardini, MD
Research Sponsored by David Lunardini
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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]
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after injury
Awards & highlights
Study Summary
This trial will compare the effectiveness of two different treatments for a type of neck fracture. One treatment is a hormone analog + immobilization in a hard collar, and the other is just immobilization in a hard collar.
Who is the study for?
This trial is for people aged 50 or older with a recent type II odontoid fracture (a specific neck bone break) that can be treated without surgery. Participants must not have used certain bone-related drugs, have no history of Paget's disease, radiation exposure to bones, or skeletal cancers. Women in the treatment group should report at least one year without menstruation.Check my eligibility
What is being tested?
The study tests if adding abaloparatide (a parathyroid hormone analog) to hard collar immobilization improves healing compared to just using the hard collar, which is the historical method. It's a pilot efficacy trial with patients being observed prospectively and compared against past cases.See study design
What are the potential side effects?
While side effects are not explicitly listed here, similar treatments like abaloparatide may cause dizziness, nausea, headache, palpitations or increase risk of osteosarcoma in those predisposed.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 years or older.
Select...
I have a specific type of neck fracture.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months after injury
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after injury
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fracture union
Secondary outcome measures
Fracture characteristics: Angulation
Fracture characteristics: Displacement
Motion
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment groupExperimental Treatment2 Interventions
Daily self-administered injection of 80 mcg abaloparatide (8 weeks) + hard collar immobilization (12 weeks)
Group II: Historical control groupActive Control1 Intervention
Patients who received only 12 weeks of hard collar immobilization
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abaloparatide
2018
Completed Phase 3
~260
Find a Location
Who is running the clinical trial?
University of VermontOTHER
266 Previous Clinical Trials
3,743,671 Total Patients Enrolled
David LunardiniLead Sponsor
David Lunardini, MDPrincipal InvestigatorUniversity of Vermont
1 Previous Clinical Trials
61 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My spine fracture can be treated without surgery, as confirmed by a specialist.I am 50 years or older.I am a woman and have not had my period for at least 12 months.I wore a hard neck brace for about 12 weeks.I have been treated for Paget's disease.I have previously used teriparatide or abaloparatide.I have used teriparatide or abaloparatide in the past.I had a bone fracture in the last 3 weeks.I have had radiation therapy or been exposed to radiation accidentally.I have had cancer spread to my bones.I have used denosumab in the last year.I have a specific type of neck fracture.I have been treated for osteosarcoma before.I have a genetic condition that increases my risk for bone cancer.I can follow strict neck brace guidelines despite my psychological condition.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment group
- Group 2: Historical control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there other examples in which Abaloparatide has been studied?
"As of now, there are 7 ongoing clinical trials for Abaloparatide with none of them in the third phase. Although a few of the investigations are situated in New york, there are a total of 11 research centres conducting studies for Abaloparatide."
Answered by AI
Are we currently able to enroll new patients for this trial?
"The trial is actively recruiting patients, as seen on clinicaltrials.gov. This trial was originally posted on 5/18/2022 and was last edited on 6/21/2022."
Answered by AI
Are there any associated risks with Abaloparatide?
"Because Abaloparatide is still in Phase 2 clinical trials, there is not yet enough data to support its efficacy. However, there is some evidence that it is safe, and so it received a score of 2."
Answered by AI
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