Denosumab Switch for Osteoporosis
Trial Summary
What is the purpose of this trial?
Investigators will test the hypothesis that an increase in bone turnover markers (e.g. carboxy-terminal collagen crosslinks (CTX) and P1NP) in patients currently taking chronic glucocorticoids will be attenuated more in those who switch from denosumab to "late" zoledronic acid (9 months after last denosumab dose) compared to participants randomized to "early" zoledronic acid (6 months after last denosumab dose) or weekly alendronate (6 months after last denosumab dose).
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 data supports the effectiveness of the drug Denosumab for osteoporosis?
Denosumab has been shown to significantly increase bone mineral density and reduce the risk of fractures in postmenopausal women with osteoporosis. It is more effective at improving bone density than continuing treatment with bisphosphonates, and it decreases vertebral fractures by 68%, nonvertebral fractures by 19%, and hip fractures by 42% over at least 36 months.12345
Is Denosumab safe for humans?
How is the drug Denosumab unique for treating osteoporosis?
Denosumab is unique because it is the first fully human monoclonal antibody that works by blocking a protein called RANK ligand, which prevents the formation and activity of cells that break down bone. It is administered as a subcutaneous injection every six months, offering a convenient dosing schedule compared to other treatments like bisphosphonates, which are often taken more frequently.138910
Eligibility Criteria
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
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
Treatment Details
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