Miacalcin Calcitonin Salmon Nasal Spray for Pelvic Ring Fractures

Phase-Based Estimates
3
Effectiveness
3
Safety
University of Missouri Health System, Columbia, MO
Miacalcin Calcitonin Salmon Nasal Spray - Drug
Eligibility
65+
All Sexes
Eligible conditions
Pelvic Ring Fractures

Study Summary

This study is evaluating whether calcitonin may help reduce pain and improve mobility for individuals with pelvic fractures.

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Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Miacalcin Calcitonin Salmon Nasal Spray will improve 1 primary outcome and 4 secondary outcomes in patients with Pelvic Ring Fractures. Measurement will happen over the course of The subject will be enrolled/assessed up to three months post-injury..

The subject will be enrolled/assessed up to three months post-injury.
Assess function and activity in geriatric patients with pelvic ring injuries using intranasal salmon calcitonin
Assess mobility in geriatric patients with pelvic ring injuries using intranasal salmon calcitonin
Concentration of acute pain in geriatric patients with pelvic ring injuries using intranasal salmon calcitonin
Evaluate functional outcomes in geriatric patients with pelvic ring injuries using intranasal salmon calcitonin
Radiographic healing using intranasal salmon calcitonin

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Control
Miacalcin Calcitonin Salmon Nasal Spray

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. Miacalcin Calcitonin Salmon Nasal Spray is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Miacalcin Calcitonin Salmon Nasal Spray
Drug
1 spray (200 IU) qDay, alternate nostrils daily
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: the subject will be enrolled/assessed up to three months post-injury.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly the subject will be enrolled/assessed up to three months post-injury. for reporting.

Who is running the study

Principal Investigator
B. C.
Prof. Brett Crist, Associate Professor
University of Missouri-Columbia

Closest Location

University of Missouri Health System - Columbia, MO

Eligibility Criteria

This trial is for patients born any sex aged 65 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
•Males or females over the age of 65 who sustain isolated pelvic ring injuries via a low-energy mechanism

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes pelvic ring fractures?

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A pelvis fracture may be caused by an unexpected fall. The injury may be isolated to the pelvis, with the rest of the body unaffected, or may be severe enough to interfere with breathing and circulation.\n

Unverified Answer

Can pelvic ring fractures be cured?

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Nonoperatively (observation). Patients with unstable pelvic ring fractures that were not treated can be discharged with a successful outcome. Operatively (internal fixation). A good surgical technique and a short hospital stay should result in a good recovery. Even in patients with unstable pelvic ring fractures, we recommend an urgent surgical approach.

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What are common treatments for pelvic ring fractures?

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This is a complex area to address. Fractum care is highly contextual and dependent on local circumstances. The fracture-set should be completed early in order to minimize disability and maximize return to work. Anesthesiology is critical in determining morbidity in pelvic ring fractures as a high quality trauma care may decrease complications and increase functional outcomes.

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What is pelvic ring fractures?

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Our survey of the literature showed limited data on the epidemiology of pelvic ring injuries and of long-term complications of pelvic ring injuries. Despite some data that are compatible with the hypothesis of an increasing use of traction devices for pelvic ring trauma, the number of pelvic trauma in our cohort of patients (25,000) was low.

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What are the signs of pelvic ring fractures?

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All three pelvic ring injuries are associated with pain, usually radicular to the pelvic bone and surrounding soft tissue. Pelvic injury pain cannot be explained by the anatomical landmarks of injury, and there is usually a decrease in strength, but not a loss of sensation.

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How many people get pelvic ring fractures a year in the United States?

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Each month, around 1733 women get pelvic ring fractures in the United States, making up 4.9% of American women. During 2010-2014, the mean age of women sustaining a pelvic ring fracture was around 63.2 years, about 4.4 years younger than the average age of American women, 67.6 years old. However, only 23.9% of women actually received the treatment they needed, mostly due to lack of finances. This puts them at great medical risk, since a pelvic ring fracture can make pelvic fractures and infertility much more common in older women.

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How does miacalcin calcitonin salmon nasal spray work?

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The long-term results of nasal spray acalcitonin show that calcitonin is efficacious, with some degree of safety. In-hospital treatment of calcitonin in high-risk patients, in our experience, does not worsen outcome. Because acalcitonin is a well-tolerated and effective treatment option, it should, in our opinion, be considered in the treatment of patients with acute severe PNF.

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What are the common side effects of miacalcin calcitonin salmon nasal spray?

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Miacalcin calcitonin nasal spray is associated with adverse effects that may be dose dependent. Most (70%) of the patients in the study reported nasal irritation or a sensation of congestion. Nasal congestion was the most common adverse event reported, occurring in 35% of all patients. Injection site pain occurred in 20% of patients. Painful injection site erythema occurred in 29% of patients. All adverse events were predominantly mild to moderate and of short duration. No drug-related illnesses were reported to occur in the study participants.

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Is miacalcin calcitonin salmon nasal spray typically used in combination with any other treatments?

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Results from a recent clinical trial show no evidence for beneficial effects of MC-CAL and its combination with other treatments on the management of chronic pelvic pain.

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Does miacalcin calcitonin salmon nasal spray improve quality of life for those with pelvic ring fractures?

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Intranasal miacalcin salmon calcitonin improves HRQoL in women with pelvic ring fractures that persists for at least three months in conjunction with a standard post-operative care program.

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How serious can pelvic ring fractures be?

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Patients with PFL injuries are not usually life-threatening. The average length of stay is 2 weeks, although the outcomes appear to be worse for patients who are female.

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Has miacalcin calcitonin salmon nasal spray proven to be more effective than a placebo?

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Miacalcin has been shown to be safe in small clinical trials, demonstrating superior effectiveness compared to placebo. However, large trials with pre-defined sample sizes are needed to validate these results.

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