- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01173081
The Use of Teriparatide as an Adjunctive Therapy for the Treatment of Jones Fractures
June 4, 2012 updated by: Ohio Orthopedic Center of Excellence
This randomized, placebo-controlled study will evaluate the effectiveness of the adjunctive use of teriparatide for the healing of Jones fractures.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
38
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Peter H. Edwards, Jr., MD
- Phone Number: 614-827-8700
- Email: LArnott@ohio-ortho.com
Study Locations
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Ohio
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Upper Arlington, Ohio, United States, 43220
- Recruiting
- Ohio Orthopedic Center of Excellence
-
Contact:
- Lindsay Arnott, BS
- Phone Number: 614-827-8375
- Email: LArnott@ohio-ortho.com
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Principal Investigator:
- Peter H. Edwards, Jr., MD
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Sub-Investigator:
- Velimir Matkovic, MD, PhD
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who are at least 18 years of age and who have closed epiphyses.
- Patients of both genders and all races.
- Patients with Jones fractures of the fifth metatarsal less than 2 weeks prior to presenting for clinical evaluation.
- Patients with a history of an acute injury and an acute Jones fracture defined by Torg et al as a fracture line with sharp margins without widening, absence of intramedullary sclerosis, and minimal or no cortical hypertrophy or evidence of periosteal changes due to chronic stress.
- Patients with either no prodromal symptoms or prodromal symptoms present less than 2 weeks.
- Patients with a baseline visual analog scale (VAS) pain score ≤ 20 (100mm scale) for the fifth metatarsal, with the foot at rest and not bearing weight.
- Patients who are in good general health and who have physical examinations that either are within normal limits or are clinically non-significant as determined by the investigator.
- Patients with laboratory evaluations that either are within normal limits or are clinically non-significant as determined by the investigator.
- Patients who have voluntarily signed informed consent forms, including HIPAA Authorization.
Exclusion Criteria:
- Patients who are younger than 18 years of age or patients who are 18 years of age or older with open epiphyses.
- Patients with Jones fractures of the fifth metatarsal greater than 2 weeks prior to presenting for clinical evaluation.
- Patients with tuberosity avulsion fractures or fifth metatarsal shaft fractures.
- Patients with prior fifth metatarsal fracture(s).
- Patients with prodromal symptoms present for more than 2 weeks.
- Patients with a nonunion or delayed union as defined by the radiographic criteria described by Torg et al.
- Patients who are allergic to any of the individual active ingredients in teriparatide or related compounds.
- Patients with chronic rheumatologic disease, ankylosing spondylitis or other inflammatory arthropathy.
- Patients with associated injuries considered by the investigator as to likely interfere with evaluation of the study drug.
- Patients with a present condition or history of any clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematologic, endocrine, neurologic, psychiatric, connective tissue, respiratory or other medical disorders.
- Patients with Worker's Compensation claim(s) under dispute or mediation.
- Patients with history of drug or alcohol abuse.
- Patients who are pregnant or lactating.
- Patients who are considered by the investigator for any reason to be an unsuitable candidate for receipt of the study drug.
- Patients who are unwilling or unable to follow the follow-up evaluation schedules.
- Patients who refuse to voluntarily sign the informed consent form.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Teriparatide
Patients randomized into this group will inject 20mcg of teriparatide once daily for 16 weeks or until the study endpoint is achieved.
Additionally, patients will take oral calcium (1,000mg) and vitamin D3 (1,000 IU) supplements daily.
|
20mcg once daily for 16 weeks or until study endpoint is achieved.
Other Names:
|
Placebo Comparator: Placebo Control
Patients randomized into this group will inject a matching dose of placebo once daily for 16 weeks or until the study endpoint is achieved.
Additionally, patients will take oral calcium (1,000mg) and vitamin D3 (1,000 IU) supplements daily.
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matching dose of 20mcg of placebo once daily for 16 weeks or until study endpoint is achieved
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fracture healing
Time Frame: weeks 4 through 24 after start of treatment
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weeks 4 through 24 after start of treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain
Time Frame: weeks 4 through 24 after start of treatment
|
weeks 4 through 24 after start of treatment
|
Range of Motion
Time Frame: weeks 4 through 24 after start of treatment
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weeks 4 through 24 after start of treatment
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Function
Time Frame: weeks 4 through 24 after start of treatment
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weeks 4 through 24 after start of treatment
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Return to Activity
Time Frame: weeks 4 through 24 after start of treatment
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weeks 4 through 24 after start of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Peter H. Edwards, Jr., MD, Ohio Orthopedic Center of Excellence
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Anticipated)
April 1, 2014
Study Completion (Anticipated)
April 1, 2014
Study Registration Dates
First Submitted
July 28, 2010
First Submitted That Met QC Criteria
July 28, 2010
First Posted (Estimate)
July 30, 2010
Study Record Updates
Last Update Posted (Estimate)
June 5, 2012
Last Update Submitted That Met QC Criteria
June 4, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B3D-US-X026
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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