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NCT03812991 · ClinicalTrials.gov registry record · Phase 4
The Use of Intranasal Calcitonin to Improve Pain and Activity in Elderly Pelvic Ring Injuries
A Phase 4 study of Pelvic Ring Fractures, sponsored by University of Missouri-Columbia.
- Completed
- Registry status
- Phase 4
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT03812991: Completed Phase 4 study of Pelvic Ring Fractures, sponsored by University of Missouri-Columbia.
NCT03812991 is a Phase 4 study of Pelvic Ring Fractures that has completed, run by University of Missouri-Columbia. The registered enrollment target is 21 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03812991, a Phase 4 study of Pelvic Ring Fractures, has completed, sponsored by University of Missouri-Columbia.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Compare acute pain using (Visual Analogue Scale on a scale of 0-10 with 0=no pain and 10= worst pain imaginable.
Conditions Studied
Interventions
- DRUG Miacalcin Calcitonin Salmon Nasal Spray
Study Locations (1)
Missouri
- University of Missouri Health System - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2019-07-01 |
| Est. Completion | 2023-02-28 |
| Phase | Phase 4 |
What the finished NCT03812991 record still lists
NCT03812991 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Pelvic Ring Fractures appearing as the primary indexed condition, and to 1 intervention - of which Miacalcin Calcitonin Salmon Nasal Spray is the first listed.
NCT03812991 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT03812991 about?
NCT03812991 is a clinical study titled "The Use of Intranasal Calcitonin to Improve Pain and Activity in Elderly Pelvic Ring Injuries". 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 th...
What is the current status of trial NCT03812991?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 21 participants. The study started on 2019-07-01. Estimated completion is 2023-02-28.
What conditions does trial NCT03812991 study?
This clinical trial studies the following conditions: Pelvic Ring Fractures.
What interventions are being tested in trial NCT03812991?
The interventions under investigation include: Miacalcin Calcitonin Salmon Nasal Spray (DRUG).
Who is sponsoring clinical trial NCT03812991?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03812991 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03812991's enrollment target sits among peer trials
21 1742nd of 2000 higher than 248 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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