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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called abaloparatide (also known as Tymlos, Eladynos, BA058, or BIM-44058) to determine if it can reduce bone loss in people with osteoporosis undergoing knee replacement surgery. The study compares two groups: one receives abaloparatide treatment, and the other does not. It seeks to discover if starting the treatment three months before surgery and continuing for 18 months can improve bone health. Suitable candidates are those with osteoporosis planning knee replacement surgery at the University of Wisconsin. As a Phase 4 trial, this research involves an FDA-approved treatment, aiming to understand its benefits for more patients.

Do I have to stop taking my current medications for the trial?

The trial requires that you have not taken certain medications like oral bisphosphonates, calcitonin, denosumab, and others within specific time frames before joining. If you're on any of these, you might need to stop or have a 'washout period' (time without taking certain medications) before participating.

What is the safety track record for abaloparatide?

Research has shown that abaloparatide is generally safe for use. Studies have found that abaloparatide effectively increases bone mineral density (BMD), strengthening bones. Specifically, abaloparatide has reduced fracture risk in individuals with osteoporosis, a condition that weakens bones.

Safety information from earlier studies included 918 patients who used abaloparatide. These studies did not reveal any new or unexpected safety issues. The reported side effects were similar to those seen with other osteoporosis treatments, such as mild reactions at the injection site.

Furthermore, the FDA has approved abaloparatide for treating osteoporosis in postmenopausal women, indicating its safety for this use. However, discussing potential risks with a healthcare provider remains important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for osteoporosis focus on slowing bone loss or increasing bone formation with oral medications or injections like bisphosphonates and denosumab. However, abaloparatide is unique because it specifically stimulates new bone growth by mimicking a hormone called PTHrP, which is crucial for bone formation. Unlike other treatments, abaloparatide is administered via a convenient injection pen, making it easier for patients to use regularly. Researchers are excited about its potential to enhance bone density significantly, especially in patients undergoing knee replacements, where strong bone health is vital for recovery and long-term success.

What evidence suggests that abaloparatide might be an effective treatment for osteoporosis in knee replacement?

Studies have shown that abaloparatide can increase bone mineral density, a measure of bone strength. Research indicates that this treatment significantly lowers fracture risk in people with osteoporosis, a condition where bones weaken and become brittle. In this trial, participants in the treatment group will receive abaloparatide, which has proven particularly effective at improving bone strength in the hip area, supporting the knee and leg bones. This suggests that abaloparatide could help reduce bone loss in patients undergoing knee replacement surgery. The treatment is already approved for patients at high risk of fractures, making it a promising option for managing bone health in these situations. ^{6 7 8 9 10}

Who Is on the Research Team?

Neil Binkley, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04167163

Abaloparatide Before Total Knee Arthroplasty

In primary unilateral total knee arthroplasty patients, The investigator will examine the effect of daily abaloparatide therapy in clinical osteoporotic ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11594069/

Effects of Abaloparatide on Bone Mineral Density in ...

Abaloparatide increases BMD in proximal femoral regions that interact with and support femoral stems, suggesting that abaloparatide may have value for ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10393898/

Advances in Osteoporosis Therapy: Focus on Osteoanabolic ...

Two osteoanabolic agents, abaloparatide and romosozumab, were recently approved for treatment of patients with osteoporosis at high fracture risk.

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0972978X2400391X

The effects of pre-operative anti-osteoporotic use on total ...

The current study aims to analyze the effect of pre-operative non-bisphosphonate anti-osteoporotic drugs on complication and revision rates following total ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0014299921005628

Abaloparatide: A review of preclinical and clinical studies

Mounting evidence from preclinical and clinical studies has uniformly reported that abaloparatide increases bone mineral density and reduces fracture risk.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38307725/

The Safety and Efficacy of Abaloparatide on ...

Abaloparatide has a protective effect on women with postmenopausal osteoporosis. It could reduce their risk for vertebral fracture; increase their BMD of the ...

7.

tymlos.com

tymlos.com/hcp/efficacy-safety/

TYMLOS Efficacy & Safety | Official HCP Website​

TYMLOS is proven to significantly increase BMD in men with osteoporosis.1,7. TYMLOS quickly and significantly increased BMD in vertebral and nonvertebral bone.1 ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01343004

NCT01343004 | Study to Evaluate the Safety and Efficacy ...

The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid hormone-related peptide, is effective in preventing fractures in ...

9.

radiuspharm.com

radiuspharm.com/presentation-data-tymlos-at-the-world-congress/

Radius Announces Presentation of Data on TYMLOS ...

In this analysis of over 18-months of treatment, abaloparatide demonstrated a lower incidence of hip fracture and non-vertebral fracture ...

10.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/nda/2017/208743Orig1s000CrossR.pdf

208743Orig1s000 - accessdata.fda.gov

The safety data for abaloparatide includes 2732 postmenopausal women with osteoporosis of which 918 received 80 mcg abaloparatide. The ...