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

NCT01173081 | Unknown Phase 4

• 1 other identifier: B3D-US-X026
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Keywords

Jones fracture; fifth metatarsal fracture; teriparatide; fracture healing

Outcome Measures

Primary Outcomes (1)

• Fracture healing

  weeks 4 through 24 after start of treatment

Secondary Outcomes (4)

• 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

Study Arms (2)

Teriparatide

EXPERIMENTAL

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

Placebo Control

PLACEBO COMPARATOR

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

Interventions

Teriparatide DRUG

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

Also known as: Forteo

Teriparatide

Placebo DRUG

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

Placebo Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio Orthopedic Center of Excellence: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Ohio Orthopedic Center of Excellence

Upper Arlington, Ohio, 43220, United States

RECRUITING

MeSH Terms

Conditions

Fractures, Bone

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Peter H. Edwards, Jr., MD

  Ohio Orthopedic Center of Excellence

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter H. Edwards, Jr., MD

CONTACT

614-827-8700; LArnott@ohio-ortho.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2010
• First Posted: July 30, 2010
• Study Start: July 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 5, 2012

Record last verified: 2012-06

Locations

US (1)