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

Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01173081
• Other study ID #: B3D-US-X026
• Status: Recruiting
• Phase: Phase 4
• First received: July 28, 2010
• Last updated: June 4, 2012
• Start date: July 2010
• Est. completion date: April 2014

Study information

• Verified date: June 2012
• Source: Ohio Orthopedic Center of Excellence
• Contact: Peter H. Edwards, Jr., MD
• Phone: 614-827-8700
• Email: LArnott[@]ohio-ortho.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Fractures
• Fractures, Bone

Intervention

Drug:
• Teriparatide
20mcg once daily for 16 weeks or until study endpoint is achieved.
• Placebo
matching dose of 20mcg of placebo once daily for 16 weeks or until study endpoint is achieved

Locations

Country	Name	City	State
United States	Ohio Orthopedic Center of Excellence	Upper Arlington	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio Orthopedic Center of Excellence	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fracture healing		weeks 4 through 24 after start of treatment	No
Secondary	Pain		weeks 4 through 24 after start of treatment	No
Secondary	Range of Motion		weeks 4 through 24 after start of treatment	No
Secondary	Function		weeks 4 through 24 after start of treatment	No
Secondary	Return to Activity		weeks 4 through 24 after start of treatment	No