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Abaloparatide for Odontoid Fracture

University of Vermont Medical Center, Burlington, VT
Odontoid FractureAbaloparatide - Drug
Eligibility
18+
All Sexes

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.

Eligible Conditions
  • Odontoid Fracture

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 3 months from injury

3 months after injury
Fracture characteristics: Angulation
Fracture characteristics: Displacement
Fracture union
Motion
Neck Disability Index
Visual Analog Scale (VAS) of neck pain
3 months from injury
Fracture characteristics
VAS pain

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Whole Egg Powder
1
One hard-boiled egg at 0 h + One hard-boiled egg at 3 h
3
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2 Treatment Groups

Historical control group
1 of 2
Treatment group
1 of 2

Active Control

Experimental Treatment

20 Total Participants · 2 Treatment Groups

Primary Treatment: Abaloparatide · No Placebo Group · Phase 2

Treatment groupExperimental Group · 2 Interventions: Abaloparatide, Hard collar immobilization · Intervention Types: Drug, Device
Historical control group
Device
ActiveComparator Group · 1 Intervention: Hard collar immobilization · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abaloparatide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months from injury

Who is running the clinical trial?

David LunardiniLead Sponsor
University of VermontOTHER
258 Previous Clinical Trials
3,741,742 Total Patients Enrolled
David Lunardini, MDPrincipal InvestigatorUniversity of Vermont
1 Previous Clinical Trials
61 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
If you have a broken bone in your spine, it can be treated without surgery according to a specialized spine doctor. (This criterion only applies to those receiving treatment, not the control group.)
You have had a bone fracture in the last 10 years if you are part of the historical control group.
You had a bone fracture within the past three weeks before agreeing to participate in the study. This only applies if you are receiving treatment in the study.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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