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| ID | Type | Description | Link |
|---|---|---|---|
| WI205578 | Other Grant/Funding Number | Pfizer |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bazedoxifene & Calcium/Vit D | Active Comparator |
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| Calcium/Vit D | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bazedoxifene | Drug | Bazedoxifene 20mg/day (Viviant) for 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Trabecular Bone Score (TBS) | Lumbar spine TBS is obtained using the spine DXA scan archived from the baseline and 48 weeks tests. It is calculated after reanalysis of the DXA scan of the L-spine using TBS iNsight® software (Version 2.0.0.1, Med-Imaps, Bordeaux, France). Vertebrae excluded in the calculation of BMD are also excluded in the TBS calculation. | Baseline and 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoon-Kyoung Sung, MD, PhD, MPH | Hanyang University Hospital for Rheumatic Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanyang University | Seoul | 04763 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38366621 | Derived | 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. | |
| 34215316 | Derived |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C447119 | bazedoxifene |
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| Calcium/Vit D | Drug | Elemental calcium 1200mg daily and vitamin D 800 IU daily (Caltrate D 400 * 2/day) for 48 weeks |
|
|
| Development of the thoracic and lumbar vertebrae for deformities by visual inspection | Baseline vertebral fracture is defined as a loss of at least 25% of vertebral height through the thoracic spine X-ray and the lumbar spine X-ray. Incident vertebral fractures at 48 weeks is diagnosed when there were distinct alterations in the morphology of the vertebral bodies that resulted in the loss of at least 25% of vertebral height of previously normal vertebrae. The location, the date of occurrence and the severity of fracture (mild, moderate, severe, etc.) are described. | Baseline and 48 weeks |
| Development of any fractures including nonvertebral fractures | Measured by the questionnaire for fracture. Check item: the location and the date of occurrence of fracture. | Baseline, 24 weeks and 48 weeks |
| Change in serum C-terminal telopeptide (CTX) | Serum C-telopeptide levels (ng/ml) are assayed by electrochemiluminescence (Roche Diagnostics, GmbH, Mannheim, Germany). Blood samples are collected after at least an 8-hour fast. | Baseline, 24 weeks and 48 weeks |
| Change in urine N-telopeptide (NTX) | Urine N-telopeptide levels (ng/ml) are measured by chemiluminescence (Ortho Clinical Diagnostics, New York, USA) using commercially available kits. Urine samples are collected after at least an 8-hour fast. | Baseline, 24 weeks and 48 weeks |
| Change in serum bone specific alkaline phosphatase | Serum bone-specific alkaline phosphatase (ALP) levels (µg/L) are also determined by electrochemiluminescence using commercial kits (Beckman Coulter Inc., Brea, USA). Blood samples are collected after at least an 8-hour fast. | Baseline, 24 weeks and 48 weeks |
| Change in serum osteocalcin | Serum osteocalcin levels (ng/mL) are also determined by electrochemiluminescence using commercial kits (Beckman Coulter Inc., Brea, USA). Blood samples are collected after at least an 8-hour fast. | Baseline, 24 weeks and 48 weeks |
| 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. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |