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

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

Study Overview

• Status: Unknown
• Conditions: Fractures
• Intervention / Treatment: Drug: Teriparatide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Upper Arlington, Ohio, United States, 43220
      • Recruiting
      • Ohio Orthopedic Center of Excellence
      • Contact: Lindsay Arnott, BS; Phone Number: 614-827-8375; Email: LArnott@ohio-ortho.com
      • Principal Investigator: Peter H. Edwards, Jr., MD
      • Sub-Investigator: Velimir Matkovic, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Teriparatide; 20mcg once daily for 16 weeks or until study endpoint is achieved.; Other Names: Forteo
Placebo Comparator: 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.	Drug: Placebo; matching dose of 20mcg of placebo once daily for 16 weeks or until study endpoint is achieved

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fracture healing	weeks 4 through 24 after start of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ohio Orthopedic Center of Excellence
• Collaborators: Eli Lilly and Company
• Investigators: Principal Investigator: Peter H. Edwards, Jr., MD, Ohio Orthopedic Center of Excellence

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Anticipated): April 1, 2014
• Study Completion (Anticipated): April 1, 2014

Study Registration Dates

• First Submitted: July 28, 2010
• First Submitted That Met QC Criteria: July 28, 2010
• First Posted (Estimate): July 30, 2010

Study Record Updates

• Last Update Posted (Estimate): June 5, 2012
• Last Update Submitted That Met QC Criteria: June 4, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: teriparatide; fracture healing; Jones fracture; fifth metatarsal fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Teriparatide
• Other Study ID Numbers: B3D-US-X026