Back to resultsEfficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women
Primary Purpose
Postmenopausal Osteoporosis
Status
Not yet recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Risedronate Sodium 35 MG [Actonel]
Calcium Vitamin D combination
Sponsored by
About this trial
This is an interventional prevention trial for Postmenopausal Osteoporosis
Eligibility Criteria
Main Inclusion Criteria: Postmenopausal women Patients diagnosed with postmenopausal osteoporosis and administered denosumab for 1 year Main Exclusion Criteria: Any contraindication to risedronate Those evaluated as inappropriate at the discretion of the investigator
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Actonel®
Arm Description
Risedronate Sodium 35mg
Outcomes
Primary Outcome Measures
Percent change from baseline in lumbar spine bone mineral density (LS BMD) at 1 year (%)
Percent change from baseline in lumbar spine bone mineral density (LS BMD) at 1 year (%)
Secondary Outcome Measures
Full Information
NCT ID
NCT05630768
First Posted
November 18, 2022
Last Updated
November 29, 2022
Sponsor
Dong-A ST Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05630768
Brief Title
Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women
Official Title
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
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2022 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
155 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Actonel®
Arm Type
Experimental
Arm Description
Risedronate Sodium 35mg
Intervention Type
Drug
Intervention Name(s)
Risedronate Sodium 35 MG [Actonel]
Intervention Description
Risendronate Sodium Tab. 35mg, orally, once weekly
Intervention Type
Drug
Intervention Name(s)
Calcium Vitamin D combination
Intervention Description
orally, once daily for concomitant drug
Primary Outcome Measure Information:
Title
Percent change from baseline in lumbar spine bone mineral density (LS BMD) at 1 year (%)
Description
Percent change from baseline in lumbar spine bone mineral density (LS BMD) at 1 year (%)
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
Postmenopausal women
Patients diagnosed with postmenopausal osteoporosis and administered denosumab for 1 year
Main Exclusion Criteria:
Any contraindication to risedronate
Those evaluated as inappropriate at the discretion of the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sung JiHyun
Phone
+82-2-920-8369
Email
jhsung@donga.co.kr
Facility Information:
Facility Name
Severance Hospital
City
Seoul
State/Province
Seodaemun-gu
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yumie Rhee
Email
yumie@yuhs.ac
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women
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