Trial Outcomes & Findings for PTH Analog Type II Odontoid Fracture (NCT NCT04760782)
NCT ID: NCT04760782
Last Updated: 2024-09-19
Results Overview
% of bridging bone on cervical CT scan
TERMINATED
PHASE2
22 participants
3 months after injury
2024-09-19
Participant Flow
Participant milestones
| Measure |
Treatment Group
Daily 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 weeks
|
Historical Control Group
Patients who received only 12 weeks of hard collar immobilization
Hard collar immobilization: Hard collar immobilization of the cervical spine for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
17
|
|
Overall Study
COMPLETED
|
1
|
17
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Count is reported of participants who did have a documented history of osteoporosis. Number analyzed is different from the overall population, because data was collected for this baseline measure from only two participants in the treatment group and 17 participants in the historical control group.
Baseline characteristics by cohort
| Measure |
Treatment Group
n=5 Participants
Daily 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 weeks
|
Historical Control Group
n=17 Participants
Patients who received only 12 weeks of hard collar immobilization
Hard collar immobilization: Hard collar immobilization of the cervical spine for 12 weeks
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
82 years
n=5 Participants
|
80 years
n=17 Participants
|
80 years
n=22 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
7 Participants
n=17 Participants
|
10 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
10 Participants
n=17 Participants
|
12 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
17 Participants
n=17 Participants
|
21 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=22 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
17 Participants
n=17 Participants
|
22 Participants
n=22 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=22 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
17 participants
n=17 Participants
|
22 participants
n=22 Participants
|
|
History of osteoporosis: Yes, No
|
0 Participants
n=2 Participants • Count is reported of participants who did have a documented history of osteoporosis. Number analyzed is different from the overall population, because data was collected for this baseline measure from only two participants in the treatment group and 17 participants in the historical control group.
|
5 Participants
n=17 Participants • Count is reported of participants who did have a documented history of osteoporosis. Number analyzed is different from the overall population, because data was collected for this baseline measure from only two participants in the treatment group and 17 participants in the historical control group.
|
5 Participants
n=19 Participants • Count is reported of participants who did have a documented history of osteoporosis. Number analyzed is different from the overall population, because data was collected for this baseline measure from only two participants in the treatment group and 17 participants in the historical control group.
|
|
History of fragility fracture: Yes, No
|
0 Participants
n=2 Participants • Count is reported of participants who did have a documented history of fragility fracture. Number analyzed is different from the overall population, because data was collected for this baseline measure from only two participants in the treatment group and 16 participants in the historical control group.
|
2 Participants
n=16 Participants • Count is reported of participants who did have a documented history of fragility fracture. Number analyzed is different from the overall population, because data was collected for this baseline measure from only two participants in the treatment group and 16 participants in the historical control group.
|
2 Participants
n=18 Participants • Count is reported of participants who did have a documented history of fragility fracture. Number analyzed is different from the overall population, because data was collected for this baseline measure from only two participants in the treatment group and 16 participants in the historical control group.
|
|
BMI
|
22 kg/m2
n=2 Participants • Data reported for participants in the treatment group only if collected before participant withdrawal.
|
24 kg/m2
n=17 Participants • Data reported for participants in the treatment group only if collected before participant withdrawal.
|
24 kg/m2
n=19 Participants • Data reported for participants in the treatment group only if collected before participant withdrawal.
|
PRIMARY outcome
Timeframe: 3 months after injuryPopulation: 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.
% of bridging bone on cervical CT scan
Outcome measures
| Measure |
Treatment Group
n=1 Participants
Daily 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 weeks
|
Historical Control Group
n=2 Participants
Patients who received only 12 weeks of hard collar immobilization
Hard collar immobilization: Hard collar immobilization of the cervical spine for 12 weeks
|
|---|---|---|
|
Fracture Union
|
0 percentage of total healing
Interval 0.0 to 0.0
|
3.6 percentage of total healing
Interval 0.0 to 7.2
|
SECONDARY outcome
Timeframe: 3 months after injuryPopulation: 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.
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.
Outcome measures
| Measure |
Treatment Group
n=1 Participants
Daily 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 weeks
|
Historical Control Group
n=2 Participants
Patients who received only 12 weeks of hard collar immobilization
Hard collar immobilization: Hard collar immobilization of the cervical spine for 12 weeks
|
|---|---|---|
|
Fracture Characteristics: Angulation
|
19.0 Degrees
Interval 19.0 to 19.0
|
36.6 Degrees
Interval 31.5 to 41.8
|
SECONDARY outcome
Timeframe: 3 months after injuryPopulation: 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.
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.
Outcome measures
| Measure |
Treatment Group
n=1 Participants
Daily 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 weeks
|
Historical Control Group
n=2 Participants
Patients who received only 12 weeks of hard collar immobilization
Hard collar immobilization: Hard collar immobilization of the cervical spine for 12 weeks
|
|---|---|---|
|
Fracture Characteristics: Displacement
|
0 mm
Interval 0.0 to 0.0
|
1.7 mm
Interval 0.7 to 2.7
|
SECONDARY outcome
Timeframe: 3 months after injuryPopulation: 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.
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
Outcome measures
| Measure |
Treatment Group
n=1 Participants
Daily 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 weeks
|
Historical Control Group
n=2 Participants
Patients who received only 12 weeks of hard collar immobilization
Hard collar immobilization: Hard collar immobilization of the cervical spine for 12 weeks
|
|---|---|---|
|
Motion
|
2.9 mm
Interval 2.9 to 2.9
|
0 mm
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 3 months after injuryPopulation: The neck disability index data reported represent percentage values. Data reported for active participants only, if evaluated before participant discontinuation/withdrawal.
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.
Outcome measures
| Measure |
Treatment Group
n=1 Participants
Daily 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 weeks
|
Historical Control Group
n=2 Participants
Patients who received only 12 weeks of hard collar immobilization
Hard collar immobilization: Hard collar immobilization of the cervical spine for 12 weeks
|
|---|---|---|
|
Neck Disability Index
|
28 percentage of 100 total points
Interval 28.0 to 28.0
|
6.5 percentage of 100 total points
Interval 3.0 to 10.0
|
SECONDARY outcome
Timeframe: 3 months after injuryPopulation: Data reported for active participants only, if evaluated before participant discontinuation/withdrawal.
This will include a patient-reported numeric scale rating of neck pain from 0 to 10, with higher scores representing increased levels of pain.
Outcome measures
| Measure |
Treatment Group
n=1 Participants
Daily 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 weeks
|
Historical Control Group
n=2 Participants
Patients who received only 12 weeks of hard collar immobilization
Hard collar immobilization: Hard collar immobilization of the cervical spine for 12 weeks
|
|---|---|---|
|
Visual Analog Scale (VAS) of Neck Pain
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
Adverse Events
Treatment Group
Historical Control Group
Serious adverse events
| Measure |
Treatment Group
n=5 participants at risk
Daily 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 weeks
|
Historical Control Group
n=2 participants at risk
Patients who received only 12 weeks of hard collar immobilization
Hard collar immobilization: Hard collar immobilization of the cervical spine for 12 weeks
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
20.0%
1/5 • Number of events 1 • Treatment group: Adverse events collected prospectively for participants enrolled to the treatment group from study consent through the 12-week study visit or until participant withdrawal/discontinuation, whichever was first. Active control participants: Adverse events collected prospectively from study consent through completion of research procedures (duration of 1 study visit only). Historical Control participants: Adverse events not reviewed retrospectively.
Systematic prospective assessment of adverse events for participants in the treatment group: regular monitoring for adverse events conducted via weekly phone calls during study treatment, and 3 monthly clinic visits during the 12-week study period. Adverse events were prospectively assessed for active control participants for the duration of research visit only. Adverse events were not assessed for historical control participants.
|
0.00%
0/2 • Treatment group: Adverse events collected prospectively for participants enrolled to the treatment group from study consent through the 12-week study visit or until participant withdrawal/discontinuation, whichever was first. Active control participants: Adverse events collected prospectively from study consent through completion of research procedures (duration of 1 study visit only). Historical Control participants: Adverse events not reviewed retrospectively.
Systematic prospective assessment of adverse events for participants in the treatment group: regular monitoring for adverse events conducted via weekly phone calls during study treatment, and 3 monthly clinic visits during the 12-week study period. Adverse events were prospectively assessed for active control participants for the duration of research visit only. Adverse events were not assessed for historical control participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dizziness; Fatigue/low energy; Respiratory failure
|
20.0%
1/5 • Number of events 1 • Treatment group: Adverse events collected prospectively for participants enrolled to the treatment group from study consent through the 12-week study visit or until participant withdrawal/discontinuation, whichever was first. Active control participants: Adverse events collected prospectively from study consent through completion of research procedures (duration of 1 study visit only). Historical Control participants: Adverse events not reviewed retrospectively.
Systematic prospective assessment of adverse events for participants in the treatment group: regular monitoring for adverse events conducted via weekly phone calls during study treatment, and 3 monthly clinic visits during the 12-week study period. Adverse events were prospectively assessed for active control participants for the duration of research visit only. Adverse events were not assessed for historical control participants.
|
0.00%
0/2 • Treatment group: Adverse events collected prospectively for participants enrolled to the treatment group from study consent through the 12-week study visit or until participant withdrawal/discontinuation, whichever was first. Active control participants: Adverse events collected prospectively from study consent through completion of research procedures (duration of 1 study visit only). Historical Control participants: Adverse events not reviewed retrospectively.
Systematic prospective assessment of adverse events for participants in the treatment group: regular monitoring for adverse events conducted via weekly phone calls during study treatment, and 3 monthly clinic visits during the 12-week study period. Adverse events were prospectively assessed for active control participants for the duration of research visit only. Adverse events were not assessed for historical control participants.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place