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

• Status: Unknown status
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio Orthopedic Center of Excellence
• Collaborator: Eli Lilly and Company
• Treatments: Teriparatide

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.