NCT05630768

Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women

A Multicenter, Open-label, Single-arm Clinical Trial to Evaluate the Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: Female
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effect of 1 year of risedronate treatment on the prevention of bone loss after denosumab discontinuation in denosumab-treated post-menopausal osteoporosis for a year

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Risedronate Sodium 35 MG [Actonel]	Risendronate Sodium Tab. 35mg, orally, once weekly
DRUG	Calcium Vitamin D combination	orally, once daily for concomitant drug

Timeline

• Start date: 2023-01-03
• Primary completion: 2025-07-23
• Completion: 2025-07-23
• First posted: 2022-11-30
• Last updated: 2025-08-24

Locations

1 site across 1 country: South Korea