Clinical trial NCT03812991: The Use of Intranasal Calcitonin to Improve Pain and Activity in Elderly Pelvic Ring Injuries
Official title: The Use of Intranasal Calcitonin to Improve Pain and Activity in Elderly Pelvic Ring Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pelvic Ring Fractures
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 21
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 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)

Eligibility 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

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: The subject will be enrolled/assessed up to three months post-injury.
Secondary outcomes:
measure: Iowa Pelvic Score (IPS)
timeFrame: The subject will be enrolled/assessed up to three months post-injury.
measure: SF-36 Short Form Health Survey
timeFrame: The subject will be enrolled/assessed up to three months post-injury.
measure: Timed Get Up and Go (TUG)
timeFrame: The subject will be assessed at the three months post-injury
measure: Radiographic Healing Using Intranasal Salmon Calcitonin
timeFrame: Fracture healing and alignment will be assessed at six weeks and three months post-injury.
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Health System
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Brett Crist, MD
role: PRINCIPAL_INVESTIGATOR
References: