Denosumab Switch for Osteoporosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the best way to transition osteoporosis patients from denosumab, a bone-strengthening medication, to other treatments to determine which option best controls bone turnover. It compares starting zoledronic acid at two different times or switching to alendronate, both alternatives for ongoing bone health. Patients who have used prednisone or similar medications for over three months and have low bone density or a history of fractures might be suitable candidates. The goal is to find the most effective way to manage bone health after stopping denosumab. As a Phase 4 trial, this research involves FDA-approved treatments and aims to enhance understanding of their benefits for more patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does require that you have been on glucocorticoids for at least 3 months and continue them for at least 6 more months. If you are taking bisphosphonates, you must not have used them in the past 2 years.
What is the safety track record for these treatments?
Studies have shown that both denosumab and zoledronic acid are safe and effective for treating osteoporosis. A large study found their safety to be similar, indicating comparable risks of side effects. This finding reassures those switching from denosumab to zoledronic acid.
Research indicates that when switching from denosumab to alendronate, alendronate effectively maintains the bone strength gained with denosumab. This suggests that the switch is generally well-tolerated.
Overall, these treatments are considered safe for managing osteoporosis, with evidence supporting their safety and effectiveness.12345Why are researchers enthusiastic about this study treatment?
Denosumab is unique because it is a monoclonal antibody that targets RANK ligand, a protein involved in the formation, function, and survival of osteoclasts, which are cells that break down bone. This mechanism is different from most standard treatments for osteoporosis, like bisphosphonates, which work by inhibiting osteoclast-mediated bone resorption. Researchers are excited about the potential of switching from Denosumab to other therapies like zoledronic acid or alendronate because it might offer a more tailored approach to maintaining bone density after initial treatment, possibly reducing the risk of rapid bone loss once Denosumab is stopped. This approach could provide more personalized and effective long-term management of osteoporosis by addressing the specific needs of patients transitioning off Denosumab.
What evidence suggests that this trial's treatments could be effective for osteoporosis?
This trial will compare different treatment strategies for osteoporosis following initial treatment with denosumab. Research has shown that denosumab reduces fracture risk more effectively than zoledronic acid in people with osteoporosis. Specifically, studies indicate that denosumab lowers fracture risk by 26% to 34% more than zoledronic acid in various scenarios. However, switching from denosumab to zoledronic acid, as tested in this trial, can make maintaining bone density challenging, with some patients experiencing about a 5.5% drop in bone mineral density (BMD). Additionally, denosumab proves more effective than alendronate, reducing fracture risk by 36% to 50% across different measures. While both zoledronic acid and alendronate are effective treatments for osteoporosis, denosumab often provides superior fracture prevention.16789
Are You a Good Fit for This Trial?
This trial is for men and women aged 18 or older who have been using glucocorticoids at a certain dose for over 3 months and will continue for at least another six. They must have osteoporosis as shown by bone density scores, or a history of fractures with less severe bone loss. Exclusions include various other bone diseases, recent cancer, dental issues, malnutrition disorders, pregnancy/breastfeeding without contraception use, and intolerance to study drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants switch from Denosumab to either early or late Zoledronic Acid or Alendronate
Follow-up
Participants are monitored for changes in bone turnover markers and safety
What Are the Treatments Tested in This Trial?
Interventions
- Denosumab
Denosumab is already approved in European Union, United States, Canada, Japan for the following indications:
- Osteoporosis in postmenopausal women
- Bone loss associated with hormone ablation therapy for prostate cancer
- Bone loss associated with hormone ablation therapy for breast cancer
- Treatment of postmenopausal women with osteoporosis at high risk for fracture
- Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
- Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer
- Treatment of osteoporosis in postmenopausal women at high risk for fracture
- Treatment to increase bone mass in men with osteoporosis at high risk for fracture
- Treatment of osteoporosis in postmenopausal women
- Treatment of bone loss associated with hormone ablation therapy for prostate cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
Vrije Universiteit Brussel
Collaborator
Maastricht University
Collaborator
Amgen
Industry Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London