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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

21 participants

Primary outcome timeframe

The subject will be enrolled/assessed up to three months post-injury.

Results posted on

2024-06-11

Participant Flow

Participant milestones

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

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

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

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

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

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-injury

Population: 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

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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Miacalcin Calcitonin Salmon Nasal Spray

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 573-882-7583

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place