Supracondylar Distal Femur Fractures and Abaloparatide
Stopped: Study withdrawn due to staffing/enrollment related challenges.
United States0Started 2024-06
Plain-language summary
Supracondylar femur fractures in the geriatric population present a unique challenge to the orthopaedic surgeon both in terms of fixation, healing, and final extremity axial alignment. Pulsed dosing of parathyroid hormone derivatives (Forteo) has been shown to increase bone mass, and several studies in Europe have demonstrated its benefit as an adjuvant for fracture healing. Abaloparatide represents a new compound which similarly offers great potential for accelerating fracture healing, especially healing associated with callous formation. This is a randomized, double blind placebo-controlled trial to compare a group of patients being treated for supracondylar distal femur fractures who receive abaloparatide (n=38) with a control group of patients who receive a placebo (n=38).
Who can participate
Age range
65 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
. Subject is ≥ 65 years old
. Subject is willing and able to read, comprehend, and sign the study informed consent form in English prior to study specific procedure
. Subject is being treated for a closed supracondylar distal femur fracture with either a retrograde nail or locked plate
. Subject undergoes open reduction/fixation
Exclusion criteria
. Subject has open fracture
. Bilateral injury or other lower extremity injury that would affect weight bearing status
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
modified Radiographic Union Score for Tibia Fractures (mRUST)
Timeframe: 6 weeks
2
maintenance of axial alignment and loss of fixation
. Subject's postoperative radiographs (on day of surgery) indicate failure to achieve axial alignment (more than 10 degrees axial alignment and more than 25% anterior/posterior displacement in lateral view)
. Subject has additional severe traumatic conditions such as closed head injury
. Subject has medical condition or is on medication that may significantly affect healing (i.e. immunosuppressive diseases and drugs)
. Subject has active or history of Paget's disease of the bone, bone cancer, or other bone diseases or conditions placing them at increased risk of osteosarcoma
. Subject has active or history of hypercalcemia or underlying hypercalcemic disorder, such as primary hyperparathyroidism