Comparative Antiresorptive Efficacy Discontinuation of Denosumab

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.

NCT Number	NCT03623633
Lead Sponsor	Massachusetts General Hospital
Conditions	Osteoporosis, Postmenopausal, Osteoporosis
Enrollment	51 participants
Start Date	2018-11-30
Primary Completion	2023-02-01 (estimated)
Study Completion	2023-08-01 (estimated)
Updated on ClinicalTrials.gov	2023-06-07