Comparative Antiresorptive Efficacy Discontinuation of Denosumab
Status:
Recruiting
Trial end date:
2025-01-01
Target enrollment:
Participant gender:
Summary
Osteoporosis remains a significant healthcare burden for the United States. Current
FDA-approved osteoporosis treatments include teriparatide, abaloparatide, bisphosphonates,
denosumab, and raloxifene.
Denosumab is a fully human monoclonal antibody that specifically binds to receptor activator
of nuclear factor kappa-B ligand (RANKL). Denosumab potently suppresses osteoclastic activity
but bone turnover rapidly normalizes and bone turnover marker levels can rebound above
baseline levels after the drug is discontinued.
This study will help us determine the optimal duration and relative efficacy of two oral
antiresorptive medications that are FDA-approved for treatment of postmenopausal osteoporosis
(alendronate and raloxifene) in preventing the rebound increase in bone turnover that occurs
after denosumab discontinuation.