CompletedPhase 4

Abaloparatide Before Total Knee Arthroplasty

United States58 participantsStarted 2020-01-10

Plain-language summary

The investigator hypothesizes that treating osteoporotic patients with abaloparatide prior to and after total knee arthroplasty will significantly reduce the amount of bone loss.

Who can participate

Age range

55 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

. Post-menopausal women and men age ge ≥ 55 years and scheduled to undergo primary TKA at the University of Wisconsin Total Joint Program.
. Osteoporosis, i.e., BMD T-score (using female reference data) ≤ -2.5 at the lumbar spine, femoral neck OR total hip or ≤ -1.1 with Vertebral Fracture Assessment confirmed vertebral fracture or history of low-trauma nonvertebral fracture in the past 5 years OR osteopenia, BMD T-score (using female reference data) -1.1 to -2.4 at the lumbar spine, femoral neck or total hip and no prior low-trauma fracture.
. Serum calcium (albumin-corrected), serum creatinine and Parathyroid(PTH) values all within the normal range and 25(OH)D \> 10 ng/mL.
. Willing to supplement with daily calcium and/or vitamin D3 at protocol specified doses.
. Able to provide written informed consent.

Exclusion criteria

. 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.
. History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic or metabolic diseases, or immunologic, emotional and/or psychiatric disturbances that, in opinion of the principal investigator, would compromise study data validity.

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

Change in Distal Femoral Bone Mineral Density (BMD) at the 25% Regions of Interest (ROIs)

Timeframe: Baseline and approximately 18 months on study (15 months post-TKA)

Trial details

NCT IDNCT04167163

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-03

Results submitted2026-03-30

View on ClinicalTrials.gov More Osteoporosis trials