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

Information source: Ohio Orthopedic Center of Excellence
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fractures

Intervention: Teriparatide (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Ohio Orthopedic Center of Excellence

Official(s) and/or principal investigator(s):
Peter H. Edwards, Jr., MD, Principal Investigator, Affiliation: Ohio Orthopedic Center of Excellence

Overall contact:
Peter H. Edwards, Jr., MD, Phone: 614-827-8700, Email: LArnott@ohio-ortho.com

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Fracture healing

Secondary outcome:

Pain

Range of Motion

Function

Return to Activity

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Peter H. Edwards, Jr., MD, Phone: 614-827-8700, Email: LArnott@ohio-ortho.com

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

Starting date: July 2010
Last updated: June 4, 2012

Page last updated: August 20, 2015

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