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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03812991

Enrollment

Registered

2019-01-23

Start date

2019-07-01

Completion date

2023-02-28

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Ring Fractures

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)

Interventions

DRUGMiacalcin Calcitonin Salmon Nasal Spray

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Visual Analogue Scale	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

Measure	Time frame	Description
Iowa Pelvic Score (IPS)	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	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)	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	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Non-Treatment Group This is the Non-Treatment Arm of the study. No intervention is to be administered.	8
Miacalcin Calcitonin Salmon Nasal Spray 1 spray (200 IU) qDay, alternate nostrils daily Miacalcin Calcitonin Salmon Nasal Spray: Miacalcin nasal spray is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily	9
Total	17

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	3	1

Baseline characteristics

Characteristic	Non-Treatment Group	Total	Miacalcin Calcitonin Salmon Nasal Spray
Age, Continuous	81 Years	81 Years	81 Years
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	8 Participants	17 Participants	9 Participants
Region of Enrollment United States	8 participants	17 participants	9 participants
Sex: Female, Male Female	6 Participants	12 Participants	6 Participants
Sex: Female, Male Male	2 Participants	5 Participants	3 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 0
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

Primary

Visual Analogue Scale

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

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