Abaloparatide for Osteoporosis in Knee Replacement

Overseen By Gretta Borchardt

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Wisconsin, Madison

Must be taking: Calcium, Vitamin D3

Must not be taking: Bisphosphonates, Calcitonin, Denosumab, others

Disqualifiers: Bone disorders, Cancer, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

58 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Neil Binkley, MD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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.

Inclusion Criteria

I am willing to take daily calcium and vitamin D3 as directed.

Able to provide written informed consent

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

I haven't had cancer in the last 5 years, except for skin cancer.

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

I am not currently taking anabolic steroids or calcineurin inhibitors.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Treatment

Participants receive daily abaloparatide therapy starting 3 months before total knee arthroplasty

12 weeks

Post-operative Treatment

Participants continue daily abaloparatide therapy after total knee arthroplasty

15 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Abaloparatide

Trial Overview 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.

Participant Groups

Group I: Comparator group Active Control 1 Intervention

Those with clinical osteopenia who receive no treatment.

Group II: Treatment group Active Control 1 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.

Abaloparatide is already approved in United States, European Union, Japan for the following indications:

Approved in United States as Tymlos for:

• Osteoporosis in postmenopausal women at high risk of fracture
• Osteoporosis in men at high risk of fracture

Approved in European Union as Eladynos for:

• Osteoporosis in postmenopausal women at increased risk of fracture

Approved in Japan as Tymlos for:

• Osteoporosis in patients at high risk of fracture

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Radius Health, Inc.

Industry Sponsor

Trials

15

Recruited

27,200+