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Efficacy 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
Dong-A ST Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postmenopausal Osteoporosis

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
November 18, 2022
Last Updated
November 29, 2022
Sponsor
Dong-A ST Co., Ltd.
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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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