CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 21 enrolled
Drug / intervention
Miacalcin Calcitonin Salmon Nasal Spraydrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03812991
NCT03812991Phase 4Completed

The Use of Intranasal Calcitonin to Improve Pain and Activity in Elderly Pelvic Ring Injuries

University of Missouri-Columbia·interventional·Posted Jan 23, 2019·Updated Jun 11, 2024

In Brief

A Phase 4 clinical trial evaluating Miacalcin Calcitonin Salmon Nasal Spray for Pelvic Ring Fractures. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJan 23, 2019
Enrollment StartJul 1, 2019
Primary CompletionSep 30, 2022
Study CompletionFeb 28, 2023
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 7.4 years ago

Interventions

Miacalcin Calcitonin Salmon Nasal Spraydrug

Miacalcin nasal spray is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily