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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