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

Phase 4

Active, not recruiting

• Conditions: Postmenopausal Osteoporosis
• Interventions: Drug: Risedronate Sodium 35 MG [Actonel]; Drug: Calcium Vitamin D combination

• Registration Number: NCT05630768
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-18
• Study First Submitted QC: 2022-11-29
• Study First Posted: 2022-11-30
• Study Start: 2023-01-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 155

Inclusion Criteria

1. Postmenopausal women
2. Patients diagnosed with postmenopausal osteoporosis and administered denosumab for 1 year

Main

Exclusion Criteria

1. Any contraindication to risedronate
2. Those evaluated as inappropriate at the discretion of the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Actonel®	Risedronate Sodium 35 MG [Actonel]	Risedronate Sodium 35mg
Actonel®	Calcium Vitamin D combination	Risedronate Sodium 35mg

Primary Outcome Measures

Name	Time	Method
Percent change from baseline in lumbar spine bone mineral density (LS BMD) at 1 year (%)	1 year	Percent change from baseline in lumbar spine bone mineral density (LS BMD) at 1 year (%)

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Seodaemun-gu, Korea, Republic of