Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women
Sponsor
Dong-A ST Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05630768
Collaborator
(none)
155
1
1
23
6.7
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
155 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Anticipated Study Start Date
:
Nov 1, 2022
Anticipated Primary Completion Date
:
Oct 1, 2024
Anticipated Study Completion Date
:
Oct 1, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Actonel® Risedronate Sodium 35mg |
Drug: Risedronate Sodium 35 MG [Actonel]
Risendronate Sodium Tab. 35mg, orally, once weekly
Drug: Calcium Vitamin D combination
orally, once daily for concomitant drug
|
Outcome Measures
Primary Outcome Measures
- 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 (%)
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Severance Hospital | Seoul | Seodaemun-gu | Korea, Republic of | 03722 |
Sponsors and Collaborators
- Dong-A ST Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05630768
Other Study ID Numbers:
- ATN_PMO_IV
First Posted:
Nov 30, 2022
Last Update Posted:
Nov 30, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: