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Osteoporosis Agent

Abaloparatide for Osteoporosis in Knee Replacement

Phase 4

Waitlist Available

Led By Neil Binkley, MD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Post-menopausal women and men age ≥ 55 years scheduled to undergo primary TKA at the University of Wisconsin Total Joint Program

Be older than 18 years old

Must not have

History of Cushing's disease, growth hormone deficiency or excess, hyperthyroidism, hypo- or hyperparathyroidism or malabsorptive syndromes within the past year

Treatment with anabolic steroids or calcineurin inhibitors (cyclosporin, tacrolimus)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will test if a medication can prevent bone loss in people with osteoporosis who are getting surgery for a knee replacement.

Who is the study for?

This trial is for post-menopausal women and men aged 55 or older with osteoporosis, scheduled for knee replacement surgery at the University of Wisconsin. They must have normal blood tests, take daily calcium and vitamin D3, and not have had certain treatments affecting bone metabolism. People with chronic diseases or a history of cancer (except some skin cancers) in the past five years are excluded.

What is being tested?

The study is testing whether abaloparatide treatment before and after total knee arthroplasty can reduce bone loss in osteoporotic patients. Participants will receive this medication alongside their surgical care to see if it improves outcomes.

What are the potential side effects?

While specific side effects aren't listed here, common ones associated with similar medications include nausea, dizziness, headache, increased heart rate, fatigue, and injection site reactions such as redness or pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a post-menopausal woman or a man aged 55 or older planning to have a knee replacement at the University of Wisconsin.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had hormone or absorption disorders in the past year.

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I am not currently taking anabolic steroids or calcineurin inhibitors.

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I have previously been treated with drugs derived from PTH or PTHrP.

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I have a bone condition that is not osteoporosis.

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I have had osteosarcoma in the past.

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I haven't taken medications like phenobarbital or heparin in the last 6 months.

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I have not used fluoride, strontium, or experimental bone treatments in the last 5 years.

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I have been taking steroids daily for the past year.

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I have had radiation therapy on my bones, not including radioiodine treatment.

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I have had kidney or bladder stones in the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Distal femoral Bone mineral density (BMD) at the 25% regions of interest (ROIs)

Secondary study objectives

Change in Distal femoral BMD at the 15% and 60 %ROI

Change in Femur cortical thickness at the 15%, 25% and 60% femur ROIs

Change in Veterans RAND 12 (VR-12) Question Health Survey score

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: Comparator groupActive Control1 Intervention

Those with clinical osteopenia who receive no treatment.

Group II: Treatment groupActive Control1 Intervention

Those with clinical osteoporosis who elect ABL treatment. ABL therapy will begin 3 months pre-TKA and continue for a total of 18 months. ABL will be administered by injection pen with dose of 80 mcg SC qDay.

0 / 11Eligibility criteria met