NCT01287533|CompletedPhase 4DMC
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Sponsor study identifier
interventional
167
1 country
1
Study Start
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2014
Actual (reported)Study Completion
April 2014
Actual (reported)This study was to investigate the efficacy of oral monthly ibandronate in the management of glucocorticoid induced osteoporosis in women with rheumatoid arthritis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
January 30, 2011
Actual (reported)February 1, 2011
Actual (reported)April 2014
Actual (reported)April 2014
Actual (reported)Changes in L1-4 bone mineral density compared with baseline
48 weeks
Changes in femur bone mineral density compared with baseline
48 weeks
Changes in L1-4 and femur bone mineral density compared with baseline
24 weeks
Changes in C-telopeptide compared with baseline
24 and 48 weeks
Cumulative incidence of vertebral fracture
48 weeks
Ibandronate 150mg PO once every 4 weeks
Placebo PO once every 4 weeks
monthly dosage of ibandronate 150mg
monthly dosage of placebo
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Seoul National University Hospital
Seoul, 110-744, South Korea
Shin K, Park SH, Park W, Baek HJ, Lee YJ, Kang SW, Choe JY, Yoo WH, Park YB, Song JS, Lee SG, Yoo B, Yoo DH, Song YW. Monthly Oral Ibandronate Reduces Bone Loss in Korean Women With Rheumatoid Arthritis and Osteopenia Receiving Long-term Glucocorticoids: A 48-week Double-blinded Randomized Placebo-controlled Investigator-initiated Trial. Clin Ther. 2017 Feb;39(2):268-278.e2. doi: 10.1016/j.clinthera.2017.01.008. Epub 2017 Feb 1.
167 participants (actual enrollment reported by the registry).
First Submitted
January 30, 2011
First Posted
February 1, 2011
Study Start
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
April 2014
Actual (reported)Study Completion
April 2014
Actual (reported)Last Updated
November 19, 2014
Record last verified: 2014-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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