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

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanyang University
• Collaborator: Pfizer
• Treatments: Bazedoxifene; Calcium; Calcium, Dietary; Glucocorticoids; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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