DRUG
Miacalcin Calcitonin Salmon Nasal Spray
Miacalcin nasal spray is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily
Status
Completed
Phase
Phase 4
Enrollment
21
Locations
1
Results
Posted
Publications
0
Study 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.
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
DRUG
Miacalcin nasal spray is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily
Timeline
First posted
Jan 23, 2019
Study start
Jul 1, 2019
Primary completion
Sep 30, 2022
Study completion
Feb 28, 2023
Results posted
Jun 11, 2024
Registry updated
Jun 11, 2024
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.
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
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
United States. Showing up to 24 locations stored in the fast local snapshot.
University of Missouri Health System
Columbia, Missouri, United States
Publications
No PMID-linked publications were present in this registry snapshot.
Related trials
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Migraine · Headache
Not applicable
Completed
513
2026-07
Jordan University of Science and Technology · Root Canal Treatment · Postoperative Pain
Not applicable
Active, not recruiting
75
2026-07
Tanta University · Calcitonin · Subcutaneous
Phase 3
Recruiting
168
2026-07
Insel Gruppe AG, University Hospital Bern · Acute Mountain Sickness
Phase 4
Not yet recruiting
30
2026-07
Institut Claudius Regaud · Medullary Thyroid Cancer
Not applicable
Completed
24
2026-06
Rigmor Højland Jensen · Idiopathic Intracranial Hypertension (IIH)
Phase 3
Not yet recruiting
96
2026-06
IRCCS San Raffaele Roma · Episodic Migraine · Chronic Migraine
Not applicable
Recruiting
2,641
2026-06
Pamukkale University · Neck Pain · Text Neck Syndrome
Not applicable
Completed
38
2026-05
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.