The Use of Teriparatide as an Adjunctive Therapy for the Treatment of Jones Fractures (NCT01173081) | Clinical Trial Compass
UnknownPhase 4
The Use of Teriparatide as an Adjunctive Therapy for the Treatment of Jones Fractures
United States38 participantsStarted 2010-07
Plain-language summary
This randomized, placebo-controlled study will evaluate the effectiveness of the adjunctive use of teriparatide for the healing of Jones fractures.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 avu…
What they're measuring
1
Fracture healing
Timeframe: weeks 4 through 24 after start of treatment