Efficacy and Safety of Actonel® After Denosumab Discontin... | NCT05630768

Studies
Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women

NCT05630768

Sponsor

Dong-A ST Co., Ltd.

Status

Completed

Last Update Posted

Aug 24, 2025Actual

Enrollment

149Actual

Phase

Phase 4

Conditions

Postmenopausal Osteoporosis

Interventions

Risedronate Sodium 35 MG [Actonel]
Calcium Vitamin D combination

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 3, 2023Actual

Primary Completion Date

Jul 23, 2025Actual

Completion Date

Jul 23, 2025Actual

First Submitted Date

Nov 18, 2022

First Submission Date that Met QC Criteria

Nov 29, 2022

First Posted Date

Nov 30, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2025

Last Update Posted Date

Aug 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

149Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Actonel®	Experimental	Risedronate Sodium 35mg	Drug: Risedronate Sodium 35 MG [Actonel] Drug: Calcium Vitamin D combination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Risedronate Sodium 35 MG [Actonel]	Drug	Risendronate Sodium Tab. 35mg, orally, once weekly	Actonel®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 (%)	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Severance Hospital		Seoul	Seodaemun-gu	03722	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D015663	Osteoporosis, Postmenopausal

Ancestor Terms

ID	Term
D010024	Osteoporosis
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068296	Risedronic Acid

Ancestor Terms

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided