Primary outcomeMean· The subject will be enrolled/assessed up to three months post-injury.
Visual Analogue Scale
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Non-Treatment Group | 6.0 | 2.0 |
| Miacalcin Calcitonin Salmon Nasal Spray | 6.8 | 2.8 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataThe Use of Intranasal Calcitonin to Improve Pain and Activity in Elderly Pelvic Ring Injuries
NCTNCT03812991 (opens ClinicalTrials.gov in a new tab)Other id2013172
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 21 participants (actual)
- Sponsor
- University of Missouri-Columbia · Other
- Design
- Randomized · Triple masking
- Countries
1 country
United States
- Start
- 1 Jul 2019
- Primary completion
- 30 Sept 2022
- Completion
- 28 Feb 2023
- First posted
- 23 Jan 2019
- Last update posted
- 11 Jun 2024
- Conditions
- Pelvic Ring Fractures
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201920202021202220232024
- Ph 4
The Use of Intranasal Calcitonin to Improve Pain and Activity in Elderly Pelvic Ring Injuries
NCT038129911 Jul 2019 to 28 Feb 2023
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Pelvic ring fractures in the geriatric population are a rising problem for surgeons in industrialized countries. Many of these low-energy fractures are treated nonoperatively; however, pain is a significant factor in recovery of these patients and often inhibits their ability to mobilize. Most of these fractures are lateral compression type 1 injuries which are defined as an impaction to the sacrum with varying amounts of anterior/pubic root/rami fractures. Many of these patients in the geriatric population suffer from osteoporosis and the injuries are often sustained from a low-energy mechanism like a fall. The tenet of treatment for all osteoporotic fractures is early mobilization. It is well known that extended periods of bed rest will lead to pneumonia, decubitus ulceration, deep venous thrombosis, and, in the case of the pelvis, not prevent subsequent deformity. Calcitonin is a polypeptide containing 32 amino acids, and it plays a role in the regulation of bone metabolism as a hormone that prevents bone resorption. Intranasal salmon calcitonin (ISC) has been demonstrated to decrease pain and improve the level of activity in patients with acute vertebral osteoporotic compression fractures when administered within the first 5 days of onset of pain/injury. It has also demonstrated an immediate post analgesic effect in osteoporotic distal radius fractures treated nonoperatively. The antihyperalgesic action of calcitonin appears to be mediated by serotonin receptors. The purpose of this study is to evaluate the analgesic effect of ISC on geriatric patients with pelvic ring injuries who are treated nonoperatively.
Interventions
- Miacalcin Calcitonin Salmon Nasal SprayDrug
Arms2
No intervention
Non-Treatment Group
This is the Non-Treatment Arm of the study. No intervention is to be administered.
Experimental
Miacalcin Calcitonin Salmon Nasal Spray
1 spray (200 IU) qDay, alternate nostrils daily
Primary outcomes1
Outcomes the sponsor listed as primary.
Visual Analogue Scale
Time frame · The subject will be enrolled/assessed up to three months post-injury.
Registry description
Compare acute pain using (Visual Analogue Scale on a scale of 0-10 with 0=no pain and 10= worst pain imaginable.
Secondary outcomes(4)
Iowa Pelvic Score (IPS)
Time frame · The subject will be enrolled/assessed up to three months post-injury.
Registry description
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).
SF-36 Short Form Health Survey
Time frame · The subject will be enrolled/assessed up to three months post-injury.
Registry description
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).
Timed Get Up and Go (TUG)
Time frame · The subject will be assessed at the three months post-injury
Registry description
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
Radiographic Healing Using Intranasal Salmon Calcitonin
Time frame · Fracture healing and alignment will be assessed at six weeks and three months post-injury.
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(4)
Secondary outcomeMean· The subject will be enrolled/assessed up to three months post-injury.
Iowa Pelvic Score (IPS)
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Non-Treatment Group | 70.5 | 18.0 |
| Miacalcin Calcitonin Salmon Nasal Spray | 64.5 | 12.0 |
Secondary outcomeMean· The subject will be enrolled/assessed up to three months post-injury.
SF-36 Short Form Health Survey
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Non-Treatment Group | 59.4 | 33.0 |
| Miacalcin Calcitonin Salmon Nasal Spray | 56.3 | 9.0 |
Secondary outcomeMean· The subject will be assessed at the three months post-injury
Timed Get Up and Go (TUG)
| Group | Value ("seconds") | Spread |
|---|---|---|
| Non-Treatment Group | 13.7 | 5.5 |
| Miacalcin Calcitonin Salmon Nasal Spray | 13.3 | 3.0 |
Secondary outcomeNumber· Fracture healing and alignment will be assessed at six weeks and three months post-injury.
Radiographic Healing Using Intranasal Salmon Calcitonin
| Group | Value (participants) |
|---|---|
| Non-Treatment Group | 8 |
| Miacalcin Calcitonin Salmon Nasal Spray | 9 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Non-Treatment GroupThis is the Non-Treatment Arm of the study. No intervention is to be administered. | 0 / 0 | 0 / 0 | 0 / 0 |
| Miacalcin Calcitonin Salmon Nasal Spray1 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 | 0 / 0 | 0 / 0 | 0 / 0 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 65 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
•Males or females over the age of 65 who sustain isolated pelvic ring injuries via a low-energy mechanism
Exclusion Criteria:
* An open pelvic ring fracture
* Concomitant acetabular fracture
* They are on ISC prior to enrollment
* Allergic or have contraindications to calcitonin or salmon
* Sustain other injuries in their spine or lower extremities
* Unwilling to participate in the study
* Nonambulatory at baseline
* Neurologic deficit associated with the pelvic ring injury
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