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

NCT ID: NCT05630768

Last Updated: 2025-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-03

Study Completion Date

2025-07-23

Brief Summary

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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

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Conditions

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Postmenopausal Osteoporosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Actonel®

Risedronate Sodium 35mg

Group Type EXPERIMENTAL

Risedronate Sodium 35 MG [Actonel]

Intervention Type DRUG

Risendronate Sodium Tab. 35mg, orally, once weekly

Calcium Vitamin D combination

Intervention Type DRUG

orally, once daily for concomitant drug

Interventions

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Risedronate Sodium 35 MG [Actonel]

Risendronate Sodium Tab. 35mg, orally, once weekly

Intervention Type DRUG

Calcium Vitamin D combination

orally, once daily for concomitant drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital

Seoul, Seodaemun-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ATN_PMO_IV

Identifier Type: -

Identifier Source: org_study_id

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