Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy
NCT ID: NCT00371956
Last Updated: 2010-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
114 participants
INTERVENTIONAL
2006-09-30
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
raloxifene
raloxifene
60mg/day
2
placebo arm
placebo
tab 1 daily
Interventions
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raloxifene
60mg/day
placebo
tab 1 daily
Eligibility Criteria
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Inclusion Criteria
2. Stable disease for at least 6 months prior to study with a stable dose of steroid (prednisone \<= 10 mg/day or equivalent).
3. Baseline bone mineral density (BMD) of the lumbar spine T score \< -1.0.
Exclusion Criteria
2. Patients with positive antiphospholipid antibodies.
3. History of allergic reactions or intolerance to raloxifene or other SERMs.
4. Patients receiving bisphosphonates, parathyroid hormone, SERMs, anticonvulsants or anti-cytokine therapies within 6 months prior to study entry.
5. Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
6. Patients with abnormal uterine bleeding of unknown etiology.
7. Patients with serum creatinine level of \>= 200 umol/L.
18 Years
FEMALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Tuen Mun Hospital
OTHER_GOV
Responsible Party
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Tuen Mun Hospital, Hong Kong
Principal Investigators
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CC MOK, MD, FRCP
Role: PRINCIPAL_INVESTIGATOR
Tuen Mun Hospital Hong Kong
Locations
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Tuen Mun Hospital
Hong Kong, , China
Countries
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References
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Mok CC, Ying KY, To CH, Ho LY, Yu KL, Lee HK, Ma KM. Raloxifene for prevention of glucocorticoid-induced bone loss: a 12-month randomised double-blinded placebo-controlled trial. Ann Rheum Dis. 2011 May;70(5):778-84. doi: 10.1136/ard.2010.143453. Epub 2010 Dec 27.
Other Identifiers
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HARECCTR0500058
Identifier Type: -
Identifier Source: org_study_id