The Use of Teriparatide as an Adjunctive Therapy for the Treatment of Jones Fractures
Status: | Completed |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/2/2016 |
Start Date: | July 2010 |
End Date: | April 2014 |
Contact: | Peter H. Edwards, Jr., MD |
Email: | LArnott@ohio-ortho.com |
Phone: | 614-827-8700 |
This randomized, placebo-controlled study will evaluate the effectiveness of the adjunctive
use of teriparatide for the healing of Jones fractures.
use of teriparatide for the healing of Jones fractures.
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.
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