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

What Was Tested

The trial (phase 4) is built around Calcitonin.

Pelvic ring fractures in the geriatric population are a rising problem for surgeons in industrialized countries.

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.

It had two arms (groups): Non-Treatment Group (no intervention) and Miacalcin Calcitonin Salmon Nasal Spray (experimental).

This is the Non-Treatment Arm of the study. No intervention is to be administered.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

Enrollment: 21 actual participants took part.

It was open to people of any sex aged from 65 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 0 inclusion and 8 exclusion criteria; among the exclusions: an open pelvic ring fracture; concomitant acetabular fracture; they are on isc prior to enrollment.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this Calcitonin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Calcitonin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and outcomes assessor.

It started in 2019-07-01 with completion listed for 2022-09-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Visual Analogue Scale (time frame: The subject will be enrolled/assessed up to three months post-injury).

It also tracked 4 secondary outcomes, for example Iowa Pelvic Score (IPS), SF-36 Short Form Health Survey, Timed Get Up and Go (TUG) and Radiographic Healing Using Intranasal Salmon Calcitonin.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Calcitonin in 21 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Calcitonin compound page, all human trials.