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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05630768
Enrollment
149
Registered
2022-11-30
Start date
2023-01-03
Completion date
2025-07-23
Last updated
2025-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal Osteoporosis

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

Interventions

DRUGRisedronate Sodium 35 MG [Actonel]

Risendronate Sodium Tab. 35mg, orally, once weekly

DRUGCalcium Vitamin D combination

orally, once daily for concomitant drug

Sponsors

Dong-A ST Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Main Inclusion Criteria: 1. Postmenopausal women 2. Patients diagnosed with postmenopausal osteoporosis and administered denosumab for 1 year Main

Exclusion criteria

1. Any contraindication to risedronate 2. Those evaluated as inappropriate at the discretion of the investigator

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026