Abaloparatide Before Total Knee Arthroplasty

What Was Tested

This registered phase 4 trial tested Abaloparatide.

It had two arms (groups): Treatment group (active comparator) and Comparator group (no intervention).

Those with clinical osteopenia who receive no treatment.

The registry classes the interventions as drug.

More on the Plan

In primary unilateral total knee arthroplasty patients, The investigator will examine the effect of daily abaloparatide therapy in clinical osteoporotic patients beginning 3 months pre-op and continued for a total of 15 months.

This will be compared to osteopenic patients receiving no therapy as well as previously published values in untreated osteoporotic patients 12 months following Total Knee Arthroplasty (TKA).

Who Took Part

Enrollment: 58 actual participants took part.

It was open to people of any sex aged from 55 years with no upper age limit.

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

Examples of who could join: Serum calcium (albumin-corrected), serum creatinine and Parathyroid(PTH) values all within the normal range and 25(OH)D \> 10 ng/mL. Able to provide written informed consent.

The full record lists 5 inclusion and 21 exclusion criteria; among the exclusions: unevaluable distal femur bmd due to hardware or other artifacts; history of bone disorders (e.g., paget's disease) other than osteoporosis; history of prior external beam or implant radiation therapy involving the skeleton other than radioiodine.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

The Abaloparatide group and the comparison group ran side by side rather than switching.

Everyone knew when Abaloparatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2020-01-10 with completion listed for 2025-04-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 11 secondary outcomes, for example Knee Injury & Osteoarthritis Outcome Score (KOOS) JR, Forgotten Joint Survey(FJS) Score, Change in Body Composition Using Bioelectrical Impedance Analysis of Lean Mass, Change in Body Composition Using Bioelectrical Impedance Analysis of Fat Mass, TKA Complications: Number of Participants Needed Revision Surgery and TKA Complications: Number of Participants Had Fracture.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Abaloparatide in 58 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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