Status:
UNKNOWN
The Use of Teriparatide as an Adjunctive Therapy for the Treatment of Jones Fractures
Lead Sponsor:
Ohio Orthopedic Center of Excellence
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Fractures
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This randomized, placebo-controlled study will evaluate the effectiveness of the adjunctive use of teriparatide for the healing of Jones fractures.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2014
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01173081
Start Date
July 1 2010
End Date
April 1 2014
Last Update
June 5 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ohio Orthopedic Center of Excellence
Upper Arlington, Ohio, United States, 43220