NCT05630768

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2023

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

January 3, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2025

Completed
Last Updated

August 24, 2025

Status Verified

December 1, 2024

Enrollment Period

2.6 years

First QC Date

November 18, 2022

Last Update Submit

August 21, 2025

Conditions

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Actonel®

EXPERIMENTAL

Risedronate Sodium 35mg

Drug: Risedronate Sodium 35 MG [Actonel]Drug: Calcium Vitamin D combination

Interventions

Risedronate Sodium 35 MG [Actonel]DRUG

Risendronate Sodium Tab. 35mg, orally, once weekly

Actonel®
Calcium Vitamin D combinationDRUG

orally, once daily for concomitant drug

Actonel®

Eligibility Criteria

Age50 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women
  • Patients diagnosed with postmenopausal osteoporosis and administered denosumab for 1 year

You may not qualify if:

  • Any contraindication to risedronate
  • Those evaluated as inappropriate at the discretion of the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, Seodaemun-gu, 03722, South Korea

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2022

First Posted

November 30, 2022

Study Start

January 3, 2023

Primary Completion

July 23, 2025

Study Completion

July 23, 2025

Last Updated

August 24, 2025

Record last verified: 2024-12

Locations

KR(1)