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

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ClinicalTrials.gov Identifier: NCT03812991
Recruitment Status : Recruiting
First Posted : January 23, 2019
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
Brett Crist, University of Missouri-Columbia

Tracking Information
First Submitted Date  ICMJE January 11, 2019
First Posted Date  ICMJE January 23, 2019
Last Update Posted Date October 28, 2019
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of Intranasal Calcitonin to Improve Pain and Activity in Elderly Pelvic Ring Injuries
Official Title  ICMJE The Use of Intranasal Calcitonin to Improve Pain and Activity in Elderly Pelvic Ring Injuries
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pelvic Ring Fractures
Intervention  ICMJE 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
Study Arms  ICMJE
  • No Intervention: Non-Treatment Group
  • Experimental: Miacalcin Calcitonin Salmon Nasal Spray
    1 spray (200 IU) qDay, alternate nostrils daily
    Intervention: Drug: Miacalcin Calcitonin Salmon Nasal Spray
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 20, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ennio Rizzo 573-882-7615 eardvb@health.missouri.edu
Contact: Stacee Clawson, BSN 573-884-9017 clawsons@health.missouri.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03812991
Other Study ID Numbers  ICMJE 2013172
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Brett Crist, University of Missouri-Columbia
Study Sponsor  ICMJE University of Missouri-Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brett Crist, MD University of Missouri-Columbia
PRS Account University of Missouri-Columbia
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP