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

NCT ID: NCT01173081

Last Updated: 2012-06-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2014-04-30

Brief Summary

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

Conditions

Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Teriparatide

Intervention Type: DRUG

20mcg once daily for 16 weeks or until study endpoint is achieved.

Placebo Control

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

matching dose of 20mcg of placebo once daily for 16 weeks or until study endpoint is achieved

Interventions

Teriparatide

20mcg once daily for 16 weeks or until study endpoint is achieved.

Intervention Type: DRUG

Placebo

matching dose of 20mcg of placebo once daily for 16 weeks or until study endpoint is achieved

Intervention Type: DRUG

Other Intervention Names

Forteo

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Ohio Orthopedic Center of Excellence

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter H. Edwards, Jr., MD

Role: PRINCIPAL_INVESTIGATOR

Ohio Orthopedic Center of Excellence

Locations

Ohio Orthopedic Center of Excellence

Upper Arlington, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Peter H. Edwards, Jr., MD

Role: CONTACT

LArnott@ohio-ortho.com

614-827-8700

Facility Contacts

Lindsay Arnott, BS

Role: primary

LArnott@ohio-ortho.com

614-827-8375

Other Identifiers

B3D-US-X026

Identifier Type: -

Identifier Source: org_study_id