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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Miacalcin Calcitonin Salmon Nasal Spray | Drug | Miacalcin nasal spray is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The subject will be enrolled/assessed up to three months post-injury. |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
|
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Inclusion Criteria:
•Males or females over the age of 65 who sustain isolated pelvic ring injuries via a low-energy mechanism
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brett Crist, MD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri Health System | Columbia | Missouri | 65212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-Treatment Group | This is the Non-Treatment Arm of the study. No intervention is to be administered. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Only participants who completed the study are included in the analysis of the data.
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-Treatment Group | This is the Non-Treatment Arm of the study. No intervention is to be administered. |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Only participants who completed the study are included in the analysis of the data. | Posted | Mean | Standard Deviation | units on a scale | The subject will be enrolled/assessed up to three months post-injury. |
|
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Deaths, serious adverse events, and other nonserious adverse events were not assessed for study participants in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-Treatment Group | This is the Non-Treatment Arm of the study. No intervention is to be administered. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vicki L Jones | UMissouri - Missouri Orthopaedic Institute | 573-882-7583 | jonesvicki@health.missouri.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 13, 2019 | Apr 29, 2024 | Prot_001.pdf |
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| ID | Term |
|---|---|
| C028815 | salmon calcitonin |
| D002116 | Calcitonin |
| ID | Term |
|---|---|
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D013963 | Thyroid Hormones |
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|
| 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). | 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 | 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. | Fracture healing and alignment will be assessed at six weeks and three months post-injury. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
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| Secondary | 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.
| Only participants who completed the study are included in the analysis of the data. | Posted | Mean | Standard Deviation | score on a scale | The subject will be enrolled/assessed up to three months post-injury. |
|
|
|
| Secondary | 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). | Only participants who completed the study are included in the analysis of the data. | Posted | Mean | Standard Deviation | score on a scale | The subject will be enrolled/assessed up to three months post-injury. |
|
|
|
| Secondary | 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 | Only participants who completed the study are included in the analysis of the data. | Posted | Mean | Standard Deviation | "seconds" | The subject will be assessed at the three months post-injury |
|
|
|
| Secondary | 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. | Only participants who completed the study are included in the analysis of the data. | Posted | Number | participants | Fracture healing and alignment will be assessed at six weeks and three months post-injury. |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| 6 Weeks Follow Up |
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| 3 Month Follow Up |
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| 6 Week Follow Up |
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| 3 Month Follow Up |
|