Zoledronic Acid Strategies After Stopping Denosumab for Postmenopausal Osteoporosis Comparing Biomarker-Guided Versus Standard Treatment to Protect Bone Density

What this Trial Is About

Researchers are investigating the best way to manage treatment withdrawal of denosumab Dmab in women with postmenopausal osteoporosis. Denosumab is an effective treatment, but stopping it can cause a rebound effect, including increased bone turnover markers, loss of bone density, and a higher risk of vertebral fractures. This study aims to compare two strategies using zoledronate ZOL infusions to reduce these rebound effects after Dmab withdrawal. Participants receive an initial ZOL infusion six months after stopping denosumab. One group receives a second ZOL infusion guided by biomarker levels crosslaps if these reach a certain threshold within one year. The other group follows a standard treatment with a potential rescue second infusion at month 12 if there is an unfavorable outcome or high risk of fractures. This open-label randomized trial tests whether biomarker-driven additional treatment offers better protection against bone loss. During the study, participants will have bone mineral density BMD measured in the lumbar spine and hip at baseline, one year, and two years. Bone turnover markers and fractures will also be monitored regularly up to two years. The main outcome is maintaining lumbar BMD after one year of zoledronate treatment. Safety and treatment response will be assessed throughout the study duration, which includes follow-up visits at months 3, 6, 9, and 12.

StrAtegies For Zoledronic Acid Post-dEnosumab Discontinuation in Postmenopausal oSTeoporosis