Recruiting

Teriparatide

Sponsor:

Ohio Orthopedic Center of Excellence

Code:

NCT01173081

Conditions

Fractures

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Teriparatide

Placebo

Study Details

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

Study ID

NCT01173081

Start date

Jul, 2010

Status verified date

Jun, 2012

Completion date

Apr, 2014

Anticipated

Primary completion date

Apr, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

38 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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

Primary outcome measure

  • Fracture healing [ Time Frame: weeks 4 through 24 after start of treatment ]

Central Contacts and Locations

Central contacts

Peter H. Edwards, Jr., MD

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

Locations

Ohio Orthopedic Center of Excellence

Recruiting

Upper Arlington, Ohio, United States, 43220

Contacts

Lindsay Arnott, BS

614-827-8375LArnott@ohio-ortho.com

Principal Investigator:

Peter H. Edwards, Jr., MD

More Information

Sponsor

Ohio Orthopedic Center of Excellence

Last update posted

Jun 5, 2012

Last verified

Jun, 2012

Keywords

  • Jones fracture
  • fifth metatarsal fracture
  • teriparatide
  • fracture healing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio Orthopedic Center of Excellence on 2012-06-05.