Abaloparatide for Osteoporosis in Knee Replacement
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.12345Why 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.678910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative Treatment
Participants receive daily abaloparatide therapy starting 3 months before total knee arthroplasty
Post-operative Treatment
Participants continue daily abaloparatide therapy after total knee arthroplasty
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Abaloparatide
Abaloparatide is already approved in United States, European Union, Japan for the following indications:
- Osteoporosis in postmenopausal women at high risk of fracture
- Osteoporosis in men at high risk of fracture
- Osteoporosis in postmenopausal women at increased risk of fracture
- Osteoporosis in patients at high risk of fracture
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Wisconsin, Madison
Lead Sponsor
Radius Health, Inc.
Industry Sponsor