Current partner codePEPTIDESDE
NCT03812991·Phase 4·INTERVENTIONAL

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

Status

Completed

Phase

Phase 4

Enrollment

21

Locations

1

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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)

Interventions

Treatment arms and agents.

DRUG

Miacalcin Calcitonin Salmon Nasal Spray

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

Timeline

From registration to results.

  1. First posted

    Jan 23, 2019

  2. Study start

    Jul 1, 2019

  3. Primary completion

    Sep 30, 2022

  4. Study completion

    Feb 28, 2023

  5. Results posted

    Jun 11, 2024

  6. Registry updated

    Jun 11, 2024

Outcomes

What the study measures.

Primary outcomes

Visual Analogue Scale

Time frame · The subject will be enrolled/assessed up to three months post-injury.

Compare acute pain using (Visual Analogue Scale on a scale of 0-10 with 0=no pain and 10= worst pain imaginable.

Secondary outcomes

Iowa Pelvic Score (IPS)

Time frame · The subject will be enrolled/assessed up to three months post-injury.

IPS is a questionnaire with 6 items subsets which are totalled to assess functional outcomes in pelvic ring injury patients. The total will range from 15 - 100 with a higher total score being associated with a better outcome. 1. activities of daily life (20 activities of daily living asking if participant can perform requiring a Yes / No response) with Yes =1, No =0. Subset Min= 0 Max=20. 2. work history (no change = 20, Fulltime, change =15, Part-Time=10, Unable=5) Subset Min= 5 Max = 20. 3. pain (None, not significant=25, Occasional medication=20, Regular medication=15, Hospitalization/operation=5) Min = 5 Max= 25. 4. limping (None=20, Yes=15, Appliance=10), and Non-ambulatory=5) Min=5 Max=20. 5. visual pain line (visual analogue scale) (Scale of 0-10 with 0=no pain and 10=worst imaginable pain) Min=0 Max=10 with higher score associated with a worse outcome. 6. cosmesis (No significance=5 and Significant change=0).

SF-36 Short Form Health Survey

Time frame · The subject will be enrolled/assessed up to three months post-injury.

SF-36 Short Form Health Survey taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Note that all items are scored so that a high score defines a more favorable health state. Each item in a scale is scored on a 0-100 range, each scale is averaged to create 8 scale scores. These scores are linearly transformed onto a scale from 0 (negative health) to 100 (positive health).

Timed Get Up and Go (TUG)

Time frame · The subject will be assessed at the three months post-injury

The 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 with scoring as noted: \< 10 seconds = normal \< 20 seconds = good mobility; can walk outside alone; does not require a walking aid \< 30 seconds = walking and balance problems; cannot walk outside alone; requires walking aid

Radiographic Healing Using Intranasal Salmon Calcitonin

Time frame · Fracture healing and alignment will be assessed at six weeks and 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.

Eligibility

Who can take part.

Minimum age
65 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

University of Missouri Health System

Columbia, Missouri, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Calcitonin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.