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

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ClinicalTrials.gov Identifier: NCT02602704
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : August 12, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Yoon-Kyoung Sung, Hanyang University

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.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: Bazedoxifene Drug: Calcium/Vit D Phase 4

Detailed 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 was a randomized, controlled, open-label study conducted for 56 weeks. Four trial visits occurred over the course of the 56 weeks. At study entry, all patients who took elemental calcium (1200 mg daily) and vitamin D (800 IU daily) were assigned by blocks of two to receive either bazedoxifene (20 mg/day) (bazedoxifene group) or not (control group).
  • Randomization was performed by an independent coordinator. Participants were followed-up at 24 weeks and 48 weeks with special attention to RA flares and occurrence of AEs.
  • Demographic characteristics such as age, sex, and medications related to RA, as well as laboratory result such as complete blood count (CBC), chemistry, and levels of inflammatory markers were collected at enrollment. BMD and trabecular bone score (TBS) were assessed at 0 and 48 weeks, and levels of bone turnover markers were assessed at 0, 24, and 48 weeks. At 56 weeks, the occurrence of AEs was assessed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectiveness of Bazedoxifene for Prevention of Glucocorticoid-induced Bone Loss in RA Patients
Actual Study Start Date : December 29, 2015
Actual Primary Completion Date : October 11, 2017
Actual Study Completion Date : December 1, 2018


Arm Intervention/treatment
Active Comparator: Bazedoxifene & Calcium/Vit D
  • 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
Bazedoxifene 20mg/day (Viviant) for 48 weeks
Other Name: Viviant

Drug: Calcium/Vit D
Elemental calcium 1200mg daily and vitamin D 800 IU daily (Caltrate D 400 * 2/day) for 48 weeks
Other Name: Hardcal Chewable

Active Comparator: Calcium/Vit D
  • Enrollment: 57
  • Drug: Elemental calcium 1200mg daily and vitamin D 800 IU daily (Caltrate D 400 * 2/day)
Drug: Calcium/Vit D
Elemental calcium 1200mg daily and vitamin D 800 IU daily (Caltrate D 400 * 2/day) for 48 weeks
Other Name: Hardcal Chewable




Primary Outcome Measures :
  1. Change of Bone Mineral Density (BMD) [ Time Frame: Baseline and 48 weeks ]
    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.


Secondary Outcome Measures :
  1. Change of Trabecular Bone Score (TBS) [ Time Frame: Baseline and 48 weeks ]
    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.

  2. Development of the thoracic and lumbar vertebrae for deformities by visual inspection [ Time Frame: Baseline and 48 weeks ]

    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.


  3. Development of any fractures including nonvertebral fractures [ Time Frame: Baseline, 24 weeks and 48 weeks ]
    Measured by the questionnaire for fracture. Check item: the location and the date of occurrence of fracture.

  4. Change in serum C-terminal telopeptide (CTX) [ Time Frame: Baseline, 24 weeks and 48 weeks ]
    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.

  5. Change in urine N-telopeptide (NTX) [ Time Frame: Baseline, 24 weeks and 48 weeks ]
    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.

  6. Change in serum bone specific alkaline phosphatase [ Time Frame: Baseline, 24 weeks and 48 weeks ]
    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.

  7. Change in serum osteocalcin [ Time Frame: Baseline, 24 weeks and 48 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602704


Locations
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Korea, Republic of
Hanyang University
Seoul, Korea, Republic of, 04763
Sponsors and Collaborators
Hanyang University
Pfizer
Investigators
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Principal Investigator: Yoon-Kyoung Sung, MD, PhD, MPH Hanyang University Hospital for Rheumatic Diseases
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Responsible Party: Yoon-Kyoung Sung, Associate professor, Hanyang University
ClinicalTrials.gov Identifier: NCT02602704    
Other Study ID Numbers: HUHRD-SPE-15-05
WI205578 ( Other Grant/Funding Number: Pfizer )
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bazedoxifene
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents