Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women
Overview
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
Full Title of Study: “A Multicenter, Open-label, Single-arm Clinical Trial to Evaluate the Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Prevention
- Masking: None (Open Label)
- Study Primary Completion Date: February 2025
Interventions
- Drug: Risedronate Sodium 35 MG [Actonel]
- Risendronate Sodium Tab. 35mg, orally, once weekly
- Drug: Calcium Vitamin D combination
- orally, once daily for concomitant drug
Arms, Groups and Cohorts
- Experimental: Actonel®
- Risedronate Sodium 35mg
Clinical Trial Outcome Measures
Primary Measures
- Percent change from baseline in lumbar spine bone mineral density (LS BMD) at 1 year (%)
- Time Frame: 1 year
- Percent change from baseline in lumbar spine bone mineral density (LS BMD) at 1 year (%)
Participating in This Clinical Trial
Main 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
Gender Eligibility: Female
Minimum Age: 50 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Dong-A ST Co., Ltd.
- Provider of Information About this Clinical Study
- Sponsor
- Overall Contact(s)
- Yumie Rhee, +82-2-2228-1973, yumie@yuhs.ac
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