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

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

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

Conditions
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Pelvic Ring Fractures

Intervention / Treatment
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* Drug: Miacalcin Calcitonin Salmon Nasal Spray


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Non-Treatment Group<br>This is the Non-Treatment Arm of the study. No intervention is to be administered. | |
| Experimental: Miacalcin Calcitonin Salmon Nasal Spray<br>1 spray (200 IU) qDay, alternate nostrils daily | Drug: Miacalcin Calcitonin Salmon Nasal Spray<br>* Miacalcin nasal spray is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily<br>* Other names: Calcitonin;|

What is the study measuring?
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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. |