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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fracture healing
Timeframe: weeks 4 through 24 after start of treatment