Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 231 for:    CALCITONIN SALMON
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03812991
Recruitment Status : Not yet recruiting
First Posted : January 23, 2019
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Brett Crist, University of Missouri-Columbia

Brief 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.

Condition or disease Intervention/treatment Phase
Pelvic Ring Fractures Drug: Miacalcin Calcitonin Salmon Nasal Spray Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Intranasal Calcitonin to Improve Pain and Activity in Elderly Pelvic Ring Injuries
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Non-Treatment Group
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




Primary Outcome Measures :
  1. Concentration of acute pain in geriatric patients with pelvic ring injuries using intranasal salmon calcitonin [ Time Frame: The subject will be enrolled/assessed up to three months post-injury. ]
    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.


Secondary Outcome Measures :
  1. Evaluate functional outcomes in geriatric patients with pelvic ring injuries using intranasal salmon calcitonin [ Time Frame: The subject will be enrolled/assessed up to three months post-injury. ]

    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.


  2. Assess function and activity in geriatric patients with pelvic ring injuries using intranasal salmon calcitonin [ Time Frame: The subject will be enrolled/assessed up to three months post-injury. ]

    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.


  3. Assess mobility in geriatric patients with pelvic ring injuries using intranasal salmon calcitonin [ Time Frame: The subject will be enrolled/assessed up to three months post-injury. ]

    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.


  4. Radiographic healing using intranasal salmon calcitonin [ Time Frame: The subject will be enrolled/assessed up to 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03812991


Contacts
Layout table for location contacts
Contact: Kelsey Anderson 573-884-4565 andersonkel@health.missouri.edu

Sponsors and Collaborators
University of Missouri-Columbia

Layout table for additonal information
Responsible Party: Brett Crist, Associate Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03812991     History of Changes
Other Study ID Numbers: 2013172
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Calcitonin
Salmon calcitonin
Calcitonin Gene-Related Peptide
Katacalcin
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Vasodilator Agents