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 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 Overview

• Status: Completed
• Conditions: Pelvic Ring Fractures
• Intervention / Treatment: Drug: Miacalcin Calcitonin Salmon Nasal Spray

Detailed Description

Baseline: Treatment group will be prescribed 200IU of ISC daily for a period of 3 months. The control group will not be prescribed calcitonin. Participants will complete research only Iowa pelvis score questionnaire, SF-36 questionnaire and visual analogue scale (VAS) to assess subjective pain and function. Two-week follow up visit post discharge: participants will complete Iowa pelvis score questionnaire, SF-36 questionnaire and VAS to assess subjective pain and function. Participants will be referred for a standard of care DEXA bone density scan if they have no previous diagnosis of osteoporosis and no history of previous scan within a year. Six weeks post discharge: participants will complete Iowa pelvis score questionnaire, SF-36 questionnaire and VAS to assess subjective pain and function. Participants will undergo standard of care radiographic analysis of pelvic ring injury with AP/inlet and outlet pelvic x-rays 4. Twelve weeks post discharge: Participants will complete Iowa pelvis score questionnaire, SF-36 questionnaire and VAS to assess subjective pain and function. Participants will undergo standard of care radiographic analysis of pelvic ring injury with AP/inlet and outlet pelvic x-rays - Participants will perform a timed up and go (TUG) test.

After informed consent is obtained, all patients who meet eligibility criteria will be randomized into one of two groups. Randomization will be achieved by numbering 50 sealed white envelopes (25 control, 25 treatment). There is no blinding to the randomization. It would be difficult to blind the participants, or the research personnel. We do not believe there will be any significant bias that can be corrected with blinding.

Treatment: 200IUof ISC daily for a period of 3 month

Control: Will not be prescribed calcitonin (ISC)

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ennio Rizzo; Phone Number: 573-882-7615; Email: eardvb@health.missouri.edu
• Study Contact Backup: Name: Stacee Clawson, BSN; Phone Number: 573-884-9017; Email: clawsons@health.missouri.edu

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Miacalcin Calcitonin Salmon Nasal Spray; Miacalcin nasal spray is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily; Other Names: Miacalcin; Calcitonin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of acute pain in geriatric patients with pelvic ring injuries using intranasal salmon calcitonin	Compare acute pain using (Visual Analogue Scale; 0-10; 0=no pain; 10= worst pain imaginable) over a three-month period in geriatric patients with pelvic ring injuries who receive intranasal salmon calcitonin with those who do not receive intranasal salmon calcitonin.	The subject will be enrolled/assessed up to three months post-injury.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate functional outcomes in geriatric patients with pelvic ring injuries using intranasal salmon calcitonin	To compare functional outcomes in pelvic ring injury patients who are treated nonoperatively and receive intranasal salmon calcitonin with those who do not receive intranasal salmon calcitonin. The activity will be tested by the below measure: Iowa Pelvic Score is pelvic injury-specific assessment comprising six items: activities of daily life, work history, pain, limping, visual pain line (visual analogue scale) and cosmesis.	The subject will be enrolled/assessed up to three months post-injury.
Assess function and activity in geriatric patients with pelvic ring injuries using intranasal salmon calcitonin	To determine if intranasal salmon calcitonin has any effect on overall health compared to those who do not receive intranasal salmon calcitonin. The activity will be tested by the below measure: SF-36 Short Form Health Survey is a measure of health-related quality-of-life questions. For example; in general, would you say your health is: Excellent, Very Good, Good, Fair, Poor.	The subject will be enrolled/assessed up to three months post-injury.
Assess mobility in geriatric patients with pelvic ring injuries using intranasal salmon calcitonin	To determine if intranasal salmon calcitonin improves a person's mobility compared to those who do not receive intranasal salmon calcitonin. The activity will be tested by the below measure: 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.	The subject will be enrolled/assessed up to three months post-injury.
Radiographic healing using intranasal salmon calcitonin	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.	The subject will be enrolled/assessed up to three months post-injury.

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: January 20, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 19, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Vasodilator Agents; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
• Other Study ID Numbers: 2013172

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes