Trial · NCT04760782
PTH Analog Type II Odontoid Fracture
NCT04760782, Phase 2, Terminated, David Lunardini; results first posted 2024-09-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PTH Analog Type II Odontoid Fracture. Trials, record NCT04760782. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04760782
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PTH Analog Type II Odontoid Fracture
- NCT number
- NCT04760782
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- David Lunardini
- Conditions
- Odontoid Fracture
- Interventions
- Abaloparatide, Hard collar immobilization
- First posted
- 2021-02-18
- Last updated
- 2024-09-19
- Results first posted
- 2024-09-19
- Limitations and caveats
- Early termination due to recruitment barriers and slow recruitment rate. Insufficient statistical power for analyses with data collected before study termination.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Fracture Union | 3 months after injury | % of bridging bone on cervical CT scan |
| Secondary | Fracture Characteristics: Angulation | 3 months after injury | 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. |
| Secondary | Fracture Characteristics: Displacement | 3 months after injury | 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. |
| Secondary | Motion | 3 months after injury | 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 |
| Secondary | Neck Disability Index | 3 months after injury | 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. |
| Secondary | Visual Analog Scale (VAS) of Neck Pain | 3 months after injury | This will include a patient-reported numeric scale rating of neck pain from 0 to 10, with higher scores representing increased levels of pain. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Fracture Union | 3 months after injury | Data analyzed and reported include all outcome data prospectively collected for this study before study termination. Outcome imaging was collected for all participants who completed the study in the treatment group (N=1) and all active control participants who completed the study (N=2). Outcome imaging was not collected from the electronic medical record for N=15 retrospectively review-only control participants before study termination. | percentage of total healing | MEDIAN |
| SECONDARY | Fracture Characteristics: Angulation | 3 months after injury | Data reported include all outcome measures prospectively collected for this study before study termination. Outcome imaging was collected for all participants who completed the study in the treatment group (N=1) and all active control participants who completed the study (N=2). Outcome imaging was not collected from the electronic medical record for N=15 retrospectively review-only control participants before study termination. | Degrees | MEDIAN |
| SECONDARY | Fracture Characteristics: Displacement | 3 months after injury | Data reported include all outcome measures prospectively collected for this study before study termination. Outcome imaging was collected for all participants who completed the study in the treatment group (N=1) and all active control participants who completed the study (N=2). Outcome imaging was not collected from the electronic medical record for N=15 retrospectively review-only control participants before study termination. | mm | MEDIAN |
| SECONDARY | Motion | 3 months after injury | Data reported include all outcome measures prospectively collected for this study before study termination. Outcome imaging was collected for all participants who completed the study in the treatment group (N=1) and all active control participants who completed the study (N=2). Outcome imaging was not collected from the electronic medical record for N=15 retrospectively review-only control participants before study termination. | mm | MEDIAN |
| SECONDARY | Neck Disability Index | 3 months after injury | The neck disability index data reported represent percentage values. Data reported for active participants only, if evaluated before participant discontinuation/withdrawal. | percentage of 100 total points | MEDIAN |
| SECONDARY | Visual Analog Scale (VAS) of Neck Pain | 3 months after injury | Data reported for active participants only, if evaluated before participant discontinuation/withdrawal. | score on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Fracture Union | Treatment Group | 0 | Full Range 0 to 0 | percentage of total healing | |
| Fracture Union | Historical Control Group | 3.6 | Full Range 0 to 7.2 | percentage of total healing | |
| Fracture Characteristics: Angulation | Treatment Group | 19.0 | Full Range 19.0 to 19.0 | Degrees | |
| Fracture Characteristics: Angulation | Historical Control Group | 36.6 | Full Range 31.5 to 41.8 | Degrees | |
| Fracture Characteristics: Displacement | Treatment Group | 0 | Full Range 0 to 0 | mm | |
| Fracture Characteristics: Displacement | Historical Control Group | 1.7 | Full Range 0.7 to 2.7 | mm | |
| Motion | Treatment Group | 2.9 | Full Range 2.9 to 2.9 | mm | |
| Motion | Historical Control Group | 0 | Full Range 0 to 0 | mm | |
| Neck Disability Index | Treatment Group | 28 | Full Range 28 to 28 | percentage of 100 total points | |
| Neck Disability Index | Historical Control Group | 6.5 | Full Range 3 to 10 | percentage of 100 total points |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Group | 5 | |
| Overall Study | STARTED | Historical Control Group | 17 | |
| Overall Study | COMPLETED | Treatment Group | 1 | |
| Overall Study | COMPLETED | Historical Control Group | 17 | |
| Overall Study | NOT COMPLETED | Treatment Group | 4 | |
| Overall Study | NOT COMPLETED | Historical Control Group | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Respiratory failure | Respiratory, thoracic and mediastinal disorders | Treatment Group | 1 | 5 | 1 |
| serious | Respiratory failure | Respiratory, thoracic and mediastinal disorders | Historical Control Group | 0 | 2 | 0 |
| serious | Dizziness; Fatigue/low energy; Respiratory failure | Respiratory, thoracic and mediastinal disorders | Treatment Group | 1 | 5 | 1 |
| serious | Dizziness; Fatigue/low energy; Respiratory failure | Respiratory, thoracic and mediastinal disorders | Historical Control Group | 0 | 2 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Group | 1 | 5 |
| Total, all-cause mortality | Historical Control Group | 0 | 2 |
| Total, other adverse events | Treatment Group | 0 | 5 |
| Total, other adverse events | Historical Control Group | 0 | 2 |
| Total, serious adverse events | Treatment Group | 1 | 5 |
| Total, serious adverse events | Historical Control Group | 0 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment Group vs Historical Control Group: deaths from any cause | Trial comparisons |
| Treatment Group vs Historical Control Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04760782
GET https://conductscience.org/api/trials/v1/NCT04760782/registered