The Use of Teriparatide as an Adjunctive Therapy for the Treatment of Jones Fractures

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Fractures

In brief

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

Key facts

Study ID

NCT01173081

Run by

Ohio Orthopedic Center of Excellence

People needed

38

Starts

2010-07-01

Expected to finish

2014-04-01

Last updated by the study team

2012-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ohio Orthopedic Center of Excellence — Upper Arlington, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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