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Hormone Therapy
The Use of Intranasal Calcitonin to Improve Pain and Activity in Elderly Pelvic Ring Injuries
Phase 4
Waitlist Available
Led By Brett Crist, MD
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up fracture healing and alignment will be assessed at six weeks and three months post-injury.
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial is testing whether a medication can help reduce pain for elderly patients with pelvic fractures who are not undergoing surgery. The medication, intranasal salmon calcitonin, is given within the first 5 days after the injury.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the subject will be enrolled/assessed up to three months post-injury.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the subject will be enrolled/assessed up to three months post-injury.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Visual Analogue Scale
Secondary study objectives
Iowa Pelvic Score (IPS)
Radiographic Healing Using Intranasal Salmon Calcitonin
SF-36 Short Form Health Survey
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Miacalcin Calcitonin Salmon Nasal SprayExperimental Treatment1 Intervention
1 spray (200 IU) qDay, alternate nostrils daily
Group II: Non-Treatment GroupActive Control1 Intervention
This is the Non-Treatment Arm of the study. No intervention is to be administered.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Miacalcin Calcitonin Salmon Nasal Spray
2019
Completed Phase 4
~30
Find a Location
Who is running the clinical trial?
University of Missouri-ColumbiaLead Sponsor
379 Previous Clinical Trials
628,561 Total Patients Enrolled
Brett Crist, MDPrincipal Investigator - University of Missouri-Columbia
Ellis Fischel Cancer Center of University of Missouri, University of Missouri Hospital
University Of Kansas School Of Medicine (Medical School)
University Ks School Of Medicine (Residency)
1 Previous Clinical Trials
35 Total Patients Enrolled