Trial Outcomes & Findings for The Use of Intranasal Calcitonin to Improve Pain and Activity in Elderly Pelvic Ring Injuries (NCT NCT03812991)
NCT ID: NCT03812991
Last Updated: 2024-06-11
Results Overview
Compare acute pain using (Visual Analogue Scale on a scale of 0-10 with 0=no pain and 10= worst pain imaginable.
COMPLETED
PHASE4
21 participants
The subject will be enrolled/assessed up to three months post-injury.
2024-06-11
Participant Flow
Participant milestones
| Measure |
Non-Treatment Group
This is the Non-Treatment Arm of the study. No intervention is to be administered.
|
Miacalcin Calcitonin Salmon Nasal Spray
1 spray (200 IU) qDay, alternate nostrils daily
Miacalcin Calcitonin Salmon Nasal Spray: Miacalcin nasal spray is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Non-Treatment Group
This is the Non-Treatment Arm of the study. No intervention is to be administered.
|
Miacalcin Calcitonin Salmon Nasal Spray
1 spray (200 IU) qDay, alternate nostrils daily
Miacalcin Calcitonin Salmon Nasal Spray: Miacalcin nasal spray is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
Baseline Characteristics
The Use of Intranasal Calcitonin to Improve Pain and Activity in Elderly Pelvic Ring Injuries
Baseline characteristics by cohort
| Measure |
Non-Treatment Group
n=8 Participants
This is the Non-Treatment Arm of the study. No intervention is to be administered.
|
Miacalcin Calcitonin Salmon Nasal Spray
n=9 Participants
1 spray (200 IU) qDay, alternate nostrils daily
Miacalcin Calcitonin Salmon Nasal Spray: Miacalcin nasal spray is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
81 Years
n=99 Participants
|
81 Years
n=107 Participants
|
81 Years
n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
9 participants
n=107 Participants
|
17 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: The subject will be enrolled/assessed up to three months post-injury.Population: Only participants who completed the study are included in the analysis of the data.
Compare acute pain using (Visual Analogue Scale on a scale of 0-10 with 0=no pain and 10= worst pain imaginable.
Outcome measures
| Measure |
Non-Treatment Group
n=8 Participants
This is the Non-Treatment Arm of the study. No intervention is to be administered.
|
Miacalcin Calcitonin Salmon Nasal Spray
n=9 Participants
1 spray (200 IU) qDay, alternate nostrils daily
Miacalcin Calcitonin Salmon Nasal Spray: Miacalcin nasal spray is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily
|
|---|---|---|
|
Visual Analogue Scale
Baseline
|
6.0 units on a scale
Standard Deviation 2.0
|
6.8 units on a scale
Standard Deviation 2.8
|
|
Visual Analogue Scale
2 Week Follow Up
|
5.5 units on a scale
Standard Deviation 2.2
|
3.7 units on a scale
Standard Deviation 3.0
|
|
Visual Analogue Scale
6 Week Follow Up
|
5.2 units on a scale
Standard Deviation 3.0
|
2.0 units on a scale
Standard Deviation 2.3
|
|
Visual Analogue Scale
3 Month Follow Up
|
1.9 units on a scale
Standard Deviation 1.4
|
2.2 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: The subject will be enrolled/assessed up to three months post-injury.Population: Only participants who completed the study are included in the analysis of the data.
IPS is a questionnaire with 6 items subsets which are totalled to assess functional outcomes in pelvic ring injury patients. The total will range from 15 - 100 with a higher total score being associated with a better outcome. 1. activities of daily life (20 activities of daily living asking if participant can perform requiring a Yes / No response) with Yes =1, No =0. Subset Min= 0 Max=20. 2. work history (no change = 20, Fulltime, change =15, Part-Time=10, Unable=5) Subset Min= 5 Max = 20. 3. pain (None, not significant=25, Occasional medication=20, Regular medication=15, Hospitalization/operation=5) Min = 5 Max= 25. 4. limping (None=20, Yes=15, Appliance=10), and Non-ambulatory=5) Min=5 Max=20. 5. visual pain line (visual analogue scale) (Scale of 0-10 with 0=no pain and 10=worst imaginable pain) Min=0 Max=10 with higher score associated with a worse outcome. 6. cosmesis (No significance=5 and Significant change=0).
Outcome measures
| Measure |
Non-Treatment Group
n=8 Participants
This is the Non-Treatment Arm of the study. No intervention is to be administered.
|
Miacalcin Calcitonin Salmon Nasal Spray
n=9 Participants
1 spray (200 IU) qDay, alternate nostrils daily
Miacalcin Calcitonin Salmon Nasal Spray: Miacalcin nasal spray is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily
|
|---|---|---|
|
Iowa Pelvic Score (IPS)
Baseline
|
70.5 score on a scale
Standard Deviation 18.0
|
64.5 score on a scale
Standard Deviation 12.0
|
|
Iowa Pelvic Score (IPS)
2 Weeks Follow Up
|
57.2 score on a scale
Standard Deviation 27.0
|
47.3 score on a scale
Standard Deviation 10.0
|
|
Iowa Pelvic Score (IPS)
6 Weeks Follow Up
|
65.7 score on a scale
Standard Deviation 10.0
|
66.3 score on a scale
Standard Deviation 12.0
|
|
Iowa Pelvic Score (IPS)
3 Month Follow Up
|
71.0 score on a scale
Standard Deviation 11.0
|
71.5 score on a scale
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: The subject will be enrolled/assessed up to three months post-injury.Population: Only participants who completed the study are included in the analysis of the data.
SF-36 Short Form Health Survey taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Note that all items are scored so that a high score defines a more favorable health state. Each item in a scale is scored on a 0-100 range, each scale is averaged to create 8 scale scores. These scores are linearly transformed onto a scale from 0 (negative health) to 100 (positive health).
Outcome measures
| Measure |
Non-Treatment Group
n=8 Participants
This is the Non-Treatment Arm of the study. No intervention is to be administered.
|
Miacalcin Calcitonin Salmon Nasal Spray
n=9 Participants
1 spray (200 IU) qDay, alternate nostrils daily
Miacalcin Calcitonin Salmon Nasal Spray: Miacalcin nasal spray is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily
|
|---|---|---|
|
SF-36 Short Form Health Survey
Baseline
|
59.4 score on a scale
Standard Deviation 33.0
|
56.3 score on a scale
Standard Deviation 9.0
|
|
SF-36 Short Form Health Survey
2 Week Follow Up
|
58.8 score on a scale
Standard Deviation 18.0
|
52.7 score on a scale
Standard Deviation 16.
|
|
SF-36 Short Form Health Survey
6 Week Follow Up
|
59.6 score on a scale
Standard Deviation 13.0
|
53.8 score on a scale
Standard Deviation 12.0
|
|
SF-36 Short Form Health Survey
3 Month Follow Up
|
58.8 score on a scale
Standard Deviation 18.0
|
53.8 score on a scale
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: The subject will be assessed at the three months post-injuryPopulation: Only participants who completed the study are included in the analysis of the data.
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down with scoring as noted: \< 10 seconds = normal \< 20 seconds = good mobility; can walk outside alone; does not require a walking aid \< 30 seconds = walking and balance problems; cannot walk outside alone; requires walking aid
Outcome measures
| Measure |
Non-Treatment Group
n=8 Participants
This is the Non-Treatment Arm of the study. No intervention is to be administered.
|
Miacalcin Calcitonin Salmon Nasal Spray
n=9 Participants
1 spray (200 IU) qDay, alternate nostrils daily
Miacalcin Calcitonin Salmon Nasal Spray: Miacalcin nasal spray is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily
|
|---|---|---|
|
Timed Get Up and Go (TUG)
|
13.7 "seconds"
Standard Deviation 5.5
|
13.3 "seconds"
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Fracture healing and alignment will be assessed at six weeks and three months post-injury.Population: Only participants who completed the study are included in the analysis of the data.
To compare radiographic healing using AP/inlet and outlet pelvic x-rays on geriatric patients with pelvic ring injuries who receive intranasal salmon calcitonin and with those who do not receive intranasal salmon calcitonin.
Outcome measures
| Measure |
Non-Treatment Group
n=8 Participants
This is the Non-Treatment Arm of the study. No intervention is to be administered.
|
Miacalcin Calcitonin Salmon Nasal Spray
n=9 Participants
1 spray (200 IU) qDay, alternate nostrils daily
Miacalcin Calcitonin Salmon Nasal Spray: Miacalcin nasal spray is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily
|
|---|---|---|
|
Radiographic Healing Using Intranasal Salmon Calcitonin
6 Week Follow Up
|
8 participants
|
9 participants
|
|
Radiographic Healing Using Intranasal Salmon Calcitonin
3 Month Follow Up
|
8 participants
|
9 participants
|
Adverse Events
Non-Treatment Group
Miacalcin Calcitonin Salmon Nasal Spray
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Vicki L Jones
UMissouri - Missouri Orthopaedic Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place