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

Dong-A ST

Status and phase: Completed; Phase 4

Conditions: Postmenopausal Osteoporosis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05630768

ATN_PMO_IV

Details and patient eligibility

About

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

Enrollment: 149 patients

Sex: Female

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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149 participants in 1 patient group

Actonel®

Experimental group

Description:

Risedronate Sodium 35mg

Treatment:

Drug: Risedronate Sodium 35 MG [Actonel]

Drug: Calcium Vitamin D combination