65 and older, any sex, with Pelvic Ring Fractures. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Visual Analogue ScalePrimary· The subject will be enrolled/assessed up to three months post-injury.
Compare acute pain using (Visual Analogue Scale on a scale of 0-10 with 0=no pain and 10= worst pain imaginable.
Baseline
Group
Value
95% CI
Non-Treatment Group
6.0
± 2.0
Miacalcin Calcitonin Salmon Nasal Spray
6.8
± 2.8
2 Week Follow Up
Group
Value
95% CI
Non-Treatment Group
5.5
± 2.2
Miacalcin Calcitonin Salmon Nasal Spray
3.7
± 3.0
6 Week Follow Up
Group
Value
95% CI
Non-Treatment Group
5.2
± 3.0
Miacalcin Calcitonin Salmon Nasal Spray
2.0
± 2.3
3 Month Follow Up
Group
Value
95% CI
Non-Treatment Group
1.9
± 1.4
Miacalcin Calcitonin Salmon Nasal Spray
2.2
± 2.3
Iowa Pelvic Score (IPS)Secondary· The subject will be enrolled/assessed up to three months post-injury.
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/oper
Baseline
Group
Value
95% CI
Non-Treatment Group
70.5
± 18.0
Miacalcin Calcitonin Salmon Nasal Spray
64.5
± 12.0
2 Weeks Follow Up
Group
Value
95% CI
Non-Treatment Group
57.2
± 27.0
Miacalcin Calcitonin Salmon Nasal Spray
47.3
± 10.0
6 Weeks Follow Up
Group
Value
95% CI
Non-Treatment Group
65.7
± 10.0
Miacalcin Calcitonin Salmon Nasal Spray
66.3
± 12.0
3 Month Follow Up
Group
Value
95% CI
Non-Treatment Group
71.0
± 11.0
Miacalcin Calcitonin Salmon Nasal Spray
71.5
± 9.0
SF-36 Short Form Health SurveySecondary· The subject will be enrolled/assessed up to three months post-injury.
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 tran
Baseline
Group
Value
95% CI
Non-Treatment Group
59.4
± 33.0
Miacalcin Calcitonin Salmon Nasal Spray
56.3
± 9.0
2 Week Follow Up
Group
Value
95% CI
Non-Treatment Group
58.8
± 18.0
Miacalcin Calcitonin Salmon Nasal Spray
52.7
± 16.
6 Week Follow Up
Group
Value
95% CI
Non-Treatment Group
59.6
± 13.0
Miacalcin Calcitonin Salmon Nasal Spray
53.8
± 12.0
3 Month Follow Up
Group
Value
95% CI
Non-Treatment Group
58.8
± 18.0
Miacalcin Calcitonin Salmon Nasal Spray
53.8
± 12.0
Timed Get Up and Go (TUG)Secondary· The subject will be assessed at the three months post-injury
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
Group
Value
95% CI
Non-Treatment Group
13.7
± 5.5
Miacalcin Calcitonin Salmon Nasal Spray
13.3
± 3.0
Radiographic Healing Using Intranasal Salmon CalcitoninSecondary· Fracture healing and alignment will be assessed at six weeks and three months post-injury.
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.
6 Week Follow Up
Group
Value
95% CI
Non-Treatment Group
8
Miacalcin Calcitonin Salmon Nasal Spray
9
3 Month Follow Up
Group
Value
95% CI
Non-Treatment Group
8
Miacalcin Calcitonin Salmon Nasal Spray
9
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University of Missouri-Columbia
Last refreshed: 11 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03812991.