Fractures
Conditions
Keywords
Jones fracture, fifth metatarsal fracture, teriparatide, fracture healing
Brief summary
This randomized, placebo-controlled study will evaluate the effectiveness of the adjunctive use of teriparatide for the healing of Jones fractures.
Interventions
DRUGTeriparatide
20mcg once daily for 16 weeks or until study endpoint is achieved.
DRUGPlacebo
matching dose of 20mcg of placebo once daily for 16 weeks or until study endpoint is achieved
Sponsors
Eli Lilly and Company
Ohio Orthopedic Center of Excellence
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fracture healing | weeks 4 through 24 after start of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Pain | weeks 4 through 24 after start of treatment |
| Range of Motion | weeks 4 through 24 after start of treatment |
| Function | weeks 4 through 24 after start of treatment |
| Return to Activity | weeks 4 through 24 after start of treatment |
Countries
United States
Contacts
Primary ContactPeter H. Edwards, Jr., MD
Outcome results
None listed