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NCT02602704

Effectiveness of Bazedoxifene for Prevention of Glucocorticoid-induced Bone Loss in RA Patients

Completed Phase 4 Last updated 12 August 2020
What this trial tests

Phase 4 trial testing Bazedoxifene in Arthritis, Rheumatoid in 114 participants. Completed in 1 December 2018.

Timeline
29 December 2015
Primary endpoint
11 October 2017
1 December 2018

Quick facts

Lead sponsorHanyang University
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment114
Start date29 December 2015
Primary completion11 October 2017
Estimated completion1 December 2018
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Hanyang University

Who can join

45 and older, female only, with Arthritis, Rheumatoid. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

* The purpose of this study is to study the effectiveness of bazedoxifene in preventing loss of bone mineral density (BMD) and trabecular bone score (TBS), and any fractures in postmenopausal rheumatoid arthritis (RA) patients receiving long-term GCs. * This is a randomized, controlled, open-label extension study for 48 or 56 weeks. At study entry, all patients will receive elemental calcium (1200 mg daily) and vitamin D (800 IU daily) and will be randomized by blocks of two to receive either bazedoxifene (20 mg/day) or none.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Effectiveness of bazedoxifene in preventing glucocorticoid-induced bone loss in rheumatoid arthritis patients.
    Cho SK, Kim H, Lee J, Nam E, et al · · 2021 · cited 8× · PMID 34215316 · DOI 10.1186/s13075-021-02564-1
  2. Comparative effectiveness of tofacitinib and tumour necrosis factor inhibitors in patients with rheumatoid arthritis in real-world practice: a prospective observational study.
    Cho SK, Song YJ, Kim HW, Nam E, et al · · 2025 · cited 1× · PMID 38366621 · DOI 10.1093/rheumatology/keae109

Verify or expand the search:

Other trials of Bazedoxifene

Trials testing the same drug.

Other recruiting trials for Arthritis, Rheumatoid

Currently open trials in the same condition.

Other Hanyang University trials

Trials by the same sponsor.

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Data sources for this page

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