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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

50 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Severance Hospital

Seoul, Seodaemun-gu, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Risedronate Sodium 35 MG [Actonel]

Drug

Risendronate Sodium Tab. 35mg, orally, once weekly

Calcium Vitamin D combination

Drug

orally, once daily for concomitant drug

Primary outcomes

Percent change from baseline in lumbar spine bone mineral density (LS BMD) at 1 year (%)

Time frame: 1 year

Percent change from baseline in lumbar spine bone mineral density (LS BMD) at 1 year (%)

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Open-label, Single-arm Clinical Trial to Evaluate the Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Nov 30, 2022
Registry last updated: Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed