Effectiveness of Bazedoxifene for Prevention of Glucocorticoid-induced Bone Loss in RA Patients
NCT02602704
ABOUT THIS STUDY
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- 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.
- 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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Descriptive Information | ||||
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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 |
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Detailed Description |
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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 |
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Study Arms ICMJE |
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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 | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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Responsible Party | Yoon-Kyoung Sung, Hanyang University | |||
Study Sponsor ICMJE | Hanyang University | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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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 |