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

NCT02602704 | Completed Phase 4

• 2 other identifiers: HUHRD-SPE-15-05WI205578
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

• Change of Bone Mineral Density (BMD)

  BMD of the L-spine (L1-4) and femur neck was assessed by dual-energy x-ray absorptiometry (DXA) (Hologic®, Discovery W, Hologic APEX software version 2.3.1; Bedford, MA, USA). BMD in the L-spine was estimated as the mean of individual measurements for L1-L4 excluding any fractured or otherwise deformed vertebrae. The technician who was responsible for measuring BMD was blinded to the details of the study.

  Baseline and 48 weeks

Secondary Outcomes (7)

• Change of Trabecular Bone Score (TBS)

  Baseline and 48 weeks

• Development of the thoracic and lumbar vertebrae for deformities by visual inspection

  Baseline and 48 weeks

• Development of any fractures including nonvertebral fractures

  Baseline, 24 weeks and 48 weeks

• Change in serum C-terminal telopeptide (CTX)

  Baseline, 24 weeks and 48 weeks

• Change in urine N-telopeptide (NTX)

  Baseline, 24 weeks and 48 weeks

Study Arms (2)

Bazedoxifene & Calcium/Vit D

ACTIVE COMPARATOR

* Enrollment: 57 * Drug: Bazedoxifene 20 mg/day (Viviant) * Drug: Elemental calcium 1200mg daily and vitamin D 800 IU daily (Caltrate D 400 \* 2/day)

Drug: Bazedoxifene; Drug: Calcium/Vit D

Calcium/Vit D

ACTIVE COMPARATOR

* Enrollment: 57 * Drug: Elemental calcium 1200mg daily and vitamin D 800 IU daily (Caltrate D 400 \* 2/day)

Drug: Calcium/Vit D

Interventions

Bazedoxifene DRUG

Bazedoxifene 20mg/day (Viviant) for 48 weeks

Also known as: Viviant

Bazedoxifene & Calcium/Vit D

Calcium/Vit D DRUG

Elemental calcium 1200mg daily and vitamin D 800 IU daily (Caltrate D 400 \* 2/day) for 48 weeks

Also known as: Hardcal Chewable

Bazedoxifene & Calcium/Vit D; Calcium/Vit D

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female RA patients ≥ 45 years old with self-reported postmenopausal for ≥12 months or prior hysterectomy with bilateral oophorectomy. Female patients ≥ 55 years old who had prior hysterectomy without oophorectomy or with unilateral oophorectomy.
• Having been receiving low to moderate dose of glucocorticoids (prednisone ≤7.5 mg/day or equivalent) for ≥3 months prior to entry. (When taking glucocorticoids PRN, prednisone ≥1mg/day in average.)
• Patients expected to be on glucocorticoid treatment for 3 months after entry.
• Patients with an osteopenic mean lumbar spine (LS; L1-L4) or femoral neck bone mineral density (BMD; -1 \< T-score \< -2.5)
• Patients who provide a written consent of participating in this study.

You may not qualify if:

• Patients with condition that may interfere with the evaluation of spinal or hip osteoporosis by DXA such as two or more vertebral (L1-L4) fractures or other vertebral deformity
• Patients with hypercoagulability risk factors or a history of deep vein thrombosis and pulmonary embolism
• History of allergic reactions or intolerance to bazedoxifene or other SERM
• Patients receiving bisphosphonates, parathyroid hormone, SERMs, or anticonvulsants therapies within 6 months prior to entry
• Patients with known bone disorders such as osteomalacia, renal osteodystrophy and hyperparathyroidism
• Patients with undiagnosed uterine bleeding
• Patients with severe renal impairment or creatinine clearance \<30ml/min

Sponsors & Collaborators

• Hanyang University: lead
• Pfizer: collaborator

Study Sites (1)

Hanyang University

Seoul, 04763, South Korea

Location

Related Publications (2)

• Cho SK, Song YJ, Kim HW, Nam E, Jeon JY, Yoo HJ, Sung YK. Comparative effectiveness of tofacitinib and tumour necrosis factor inhibitors in patients with rheumatoid arthritis in real-world practice: a prospective observational study. Rheumatology (Oxford). 2025 Feb 1;64(2):541-547. doi: 10.1093/rheumatology/keae109.

  PMID: 38366621 DERIVED

• Cho SK, Kim H, Lee J, Nam E, Lee S, Choi YY, Sung YK. Effectiveness of bazedoxifene in preventing glucocorticoid-induced bone loss in rheumatoid arthritis patients. Arthritis Res Ther. 2021 Jul 2;23(1):176. doi: 10.1186/s13075-021-02564-1.

  PMID: 34215316 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

bazedoxifene

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Yoon-Kyoung Sung, MD, PhD, MPH

  Hanyang University Hospital for Rheumatic Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 11, 2015
• Study Start: December 29, 2015
• Primary Completion: October 11, 2017
• Study Completion: December 1, 2018
• Last Updated: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)