Upper Arlington, Ohio 43220


Purpose:

This randomized, placebo-controlled study will evaluate the effectiveness of the adjunctive use of teriparatide for the healing of Jones fractures.


Criteria:

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.


NCT ID:

NCT01173081


Primary Contact:

Principal Investigator
Peter H. Edwards, Jr., MD
Ohio Orthopedic Center of Excellence

Peter H. Edwards, Jr., MD
Phone: 614-827-8700
Email: LArnott@ohio-ortho.com


Backup Contact:

N/A


Location Contact:

Upper Arlington, Ohio 43220
United States

Lindsay Arnott, BS
Phone: 614-827-8375
Email: LArnott@ohio-ortho.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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