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

Phase 4

• Conditions: Fractures
• Interventions: Drug: Placebo; Drug: Teriparatide

• Registration Number: NCT01173081
• Lead Sponsor: Ohio Orthopedic Center of Excellence

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-28
• Study First Submitted QC: 2010-07-28
• Study First Posted: 2010-07-30
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-04
• Last Update Posted: 2012-06-05
• Primary Completion: 2014-04
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Control	Placebo	Patients randomized into this group will inject a matching dose of placebo once daily for 16 weeks or until the study endpoint is achieved. Additionally, patients will take oral calcium (1,000mg) and vitamin D3 (1,000 IU) supplements daily.
Teriparatide	Teriparatide	Patients randomized into this group will inject 20mcg of teriparatide once daily for 16 weeks or until the study endpoint is achieved. Additionally, patients will take oral calcium (1,000mg) and vitamin D3 (1,000 IU) supplements daily.

Primary Outcome Measures

Name	Time	Method
Fracture healing	weeks 4 through 24 after start of treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ohio Orthopedic Center of Excellence; 🇺🇸 Upper Arlington, Ohio, United States