Pelvic Ring FracturesPhase 4NCT03812991
The Use of Intranasal Calcitonin to Improve Pain and Activity in Elderly Pelvic Ring Injuries
A Phase 4 study testing Miacalcin Calcitonin Salmon Nasal Spray in people with Pelvic Ring Fractures, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pelvic Ring Fractures
- What is being tested?
- Miacalcin Calcitonin Salmon Nasal Spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 28 Feb 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- •Males or females over the age of 65 who sustain isolated pelvic ring injuries via a low-energy mechanism
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri Health System
Columbia, Missouri, 65212
About this study
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.
Read the 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)
- Conditions
- Pelvic Ring Fractures
- Being tested
- Miacalcin Calcitonin Salmon Nasal Spray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miacalcin Calcitonin Salmon Nasal SprayDrug
Also called Miacalcin, Calcitonin
Miacalcin nasal spray is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily
| Study group | Role | What they receive |
|---|---|---|
| Non-Treatment Group | No intervention | This is the Non-Treatment Arm of the study. No intervention is to be administered. |
| Miacalcin Calcitonin Salmon Nasal Spray | Experimental | 1 spray (200 IU) qDay, alternate nostrils daily Receives: Drug: Miacalcin Calcitonin Salmon Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The subject will be enrolled/assessed up to three months post-injury.
Secondary outcomes (4)
Iowa Pelvic Score (IPS)
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.
- 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.
- work history (no change = 20, Fulltime, change =15, Part-Time=10, Unable=5) Subset Min= 5 Max = 20.
- pain (None, not significant=25, Occasional medication=20, Regular medication=15, Hospitalization/operation=5) Min = 5 Max= 25.
- limping (None=20, Yes=15, Appliance=10), and Non-ambulatory=5) Min=5 Max=20.
- 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.
- cosmesis (No significance=5 and Significant change=0).
Measured: The subject will be enrolled/assessed up to three months post-injury.
SF-36 Short Form Health Survey
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).
Measured: The subject will be enrolled/assessed up to three months post-injury.
Timed Get Up and Go (TUG)
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
Measured: The subject will be assessed at the three months post-injury
Radiographic Healing Using Intranasal Salmon Calcitonin
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.
Measured: Fracture healing and alignment will be assessed at six weeks and three months post-injury.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start1 Jul 2019
- Primary completion30 Sep 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pelvic Ring FracturesStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brett D. Crist, University of Missouri-Columbia
- Investigators
- Brett Crist, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812991
- Sponsor's protocol ID
- 2013172
- Status last verified
- Jun 2024
- First submitted
- 11 Jan 2019
- Last updated
- 11 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Intranasal Calcitonin to Improve Pain and Activity in Elderly Pelvic Ring Injuries
- ClinicalTrials.gov ID
- NCT03812991
- Acronym / sponsor ID
- 2013172
- Conditions
- Pelvic Ring Fractures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 23 Jan 2019 (actual)
- Results
- Posted 11 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Treatment Group | No intervention | –This is the Non-Treatment Arm of the study. No intervention is to be administered. |
| Miacalcin Calcitonin Salmon Nasal Spray | Experimental | Drug: Miacalcin Calcitonin Salmon Nasal Spray1 spray (200 IU) qDay, alternate nostrils daily |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- •Males or females over the age of 65 who sustain isolated pelvic ring injuries via a low-energy mechanism
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Miacalcin Calcitonin Salmon Nasal SprayAlso: Miacalcin, CalcitoninMiacalcin nasal spray is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily | Drug | Miacalcin Calcitonin Salmon Nasal Spray |
Primary outcome
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.
4 secondary outcomes
Iowa Pelvic Score (IPS)
Time frame: The subject will be enrolled/assessed up to three months post-injury.
SF-36 Short Form Health Survey
Time frame: The subject will be enrolled/assessed up to three months post-injury.
Timed Get Up and Go (TUG)
Time frame: The subject will be assessed at the three months post-injury
Radiographic Healing Using Intranasal Salmon Calcitonin
Time frame: Fracture healing and alignment will be assessed at six weeks and three months post-injury.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett Crist, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Miacalcin Calcitonin Salmon Nasal Spray in people with Pelvic Ring Fractures, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: The subject will be enrolled/assessed up to three months post-injury.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.