Supracondylar Distal Femur Fractures and Abaloparatide

What Was Tested

The trial (phase 4) is built around Abaloparatide.

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.

It had two arms (groups): Abaloparatide group (experimental) and Control group (placebo comparator).

Patients in the experimental group will receive abaloparatide after their surgery.

Patients in the control group will receive a placebo after their surgery.

The registry classes the interventions as drug.

More on the Plan

Multiple methods of fixation are well accepted, and each has its own advantages and disadvantages.

The common occurrence of periprosthetic supracondylar femur fractures adds another level of complexity, and the universal goal when treating these patients is to obtain and maintain acceptable alignment, allow mobilization and early weight bearing, and achieve union.

To a degree, mobilization and weight bearing compete with maintenance of axial alignment, and any final outcome is a race between healing and loss of fixation.

Who Took Part

It was open to people of any sex aged from 65 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: subject has open fracture; bilateral injury or other lower extremity injury that would affect weight bearing status; subject has additional severe traumatic conditions such as closed head injury.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Abaloparatide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Abaloparatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-06 with completion listed for 2025-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: modified Radiographic Union Score for Tibia Fractures (mRUST) (time frame: 6 weeks). maintenance of axial alignment and loss of fixation (time frame: 6 weeks).

It also tracked 4 secondary outcomes, for example modified Radiographic Union Score for Tibia Fractures (mRUST), modified Radiographic Union Score for Tibia Fractures (mRUST), maintenance of axial alignment and loss of fixation and maintenance of axial alignment and loss of fixation.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Abaloparatide in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Abaloparatide compound page, all human trials.