Clinical trial NCT01173081: The Use of Teriparatide as an Adjunctive Therapy for the Treatment of Jones Fractures
Official title: The Use of Teriparatide as an Adjunctive Therapy for the Treatment of Jones Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Fractures
Keywords: Jones fracture
fifth metatarsal fracture
teriparatide
fracture healing
Lead sponsor: Ohio Orthopedic Center of Excellence
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2010-07-30
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Fracture healing
timeFrame: weeks 4 through 24 after start of treatment
Secondary outcomes:
measure: Pain
timeFrame: weeks 4 through 24 after start of treatment
measure: Range of Motion
timeFrame: weeks 4 through 24 after start of treatment
measure: Function
timeFrame: weeks 4 through 24 after start of treatment
measure: Return to Activity
timeFrame: weeks 4 through 24 after start of treatment
Other outcomes:
Locations:
city: Upper Arlington
country: United States
facility: Ohio Orthopedic Center of Excellence
state: Ohio
Study officials:
affiliation: Ohio Orthopedic Center of Excellence
name: Peter H. Edwards, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References: