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

NCT02602704

Last updated date
Study Location
Hanyang University
Seoul, , 04763, Korea, Republic of
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Effectiveness of Bazedoxifene for Prevention of Glucocorticoid-induced Bone Loss in RA Patients
Official Title  ICMJE Effectiveness of Bazedoxifene for Prevention of Glucocorticoid-induced Bone Loss in RA Patients
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)
    Interventions:
    • Drug: Bazedoxifene
    • Drug: Calcium/Vit D
  • Active Comparator: Calcium/Vit D
    • Enrollment: 57
    • Drug: Elemental calcium 1200mg daily and vitamin D 800 IU daily (Caltrate D 400 * 2/day)
    Intervention: Drug: Calcium/Vit D
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 10, 2015)
114
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 1, 2018
Actual Primary Completion Date October 11, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02602704
Other Study ID Numbers  ICMJE HUHRD-SPE-15-05
WI205578 ( Other Grant/Funding Number: Pfizer )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Yoon-Kyoung Sung, Hanyang University
Study Sponsor  ICMJE Hanyang University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Yoon-Kyoung Sung, MD, PhD, MPHHanyang University Hospital for Rheumatic Diseases
PRS Account Hanyang University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP