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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Ohio Orthopedic Center of Excellence.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Ohio Orthopedic Center of Excellence
ClinicalTrials.gov Identifier:
NCT01173081
First received: July 28, 2010
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Fractures
Drug: Teriparatide
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Use of Teriparatide as an Adjunctive Therapy for the Treatment of Jones Fractures

Resource links provided by NLM:


Further study details as provided by Ohio Orthopedic Center of Excellence:

Primary Outcome Measures:
  • Fracture healing [ Time Frame: weeks 4 through 24 after start of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain [ Time Frame: weeks 4 through 24 after start of treatment ] [ Designated as safety issue: No ]
  • Range of Motion [ Time Frame: weeks 4 through 24 after start of treatment ] [ Designated as safety issue: No ]
  • Function [ Time Frame: weeks 4 through 24 after start of treatment ] [ Designated as safety issue: No ]
  • Return to Activity [ Time Frame: weeks 4 through 24 after start of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 38
Study Start Date: July 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01173081

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

Locations
United States, Ohio
Ohio Orthopedic Center of Excellence Recruiting
Upper Arlington, Ohio, United States, 43220
Contact: Lindsay Arnott, BS    614-827-8375    LArnott@ohio-ortho.com   
Principal Investigator: Peter H. Edwards, Jr., MD         
Sub-Investigator: Velimir Matkovic, MD, PhD         
Sponsors and Collaborators
Ohio Orthopedic Center of Excellence
Eli Lilly and Company
Investigators
Principal Investigator: Peter H. Edwards, Jr., MD Ohio Orthopedic Center of Excellence
  More Information

No publications provided

Responsible Party: Ohio Orthopedic Center of Excellence
ClinicalTrials.gov Identifier: NCT01173081     History of Changes
Other Study ID Numbers: B3D-US-X026
Study First Received: July 28, 2010
Last Updated: June 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio Orthopedic Center of Excellence:
Jones fracture
fifth metatarsal fracture
teriparatide
fracture healing

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014