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Sponsor study identifier
Secondary identifiers
observational
120
1 country
2
Study Start
May 4, 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
January 11, 2017
Date type not reportedThis date has not been verified as actual or estimated.
Background: \- Osteoporosis is a condition where the bone becomes more brittle and more likely to break as a person ages. The drugs that people take to treat this condition have prevented many common hip fractures. But these drugs may be associated with problems in the shape and structure of the hip bone after many years of use. These changes in the hip bone may lead to an unusual kind of hip fracture. These fractures are very rare, so it is hard to study them. Researchers want to learn more about these fractures. Objectives: \- To compare hip x-rays of three groups: people who have been taking osteoporosis drugs for several years, those who have just started taking them, and those who have never taken these drugs. Eligibility:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 11, 2017
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 4, 2011
Date type not reportedThis date has not been verified as actual or estimated.
May 20, 2011
Actual (reported)May 25, 2011
Actual (reported)January 11, 2017
Date type not reportedThis date has not been verified as actual or estimated.
Difference in prevalence of cortical thickening and beaking between long term users vs. short term or non-users of bisphosphonates.
Difference in rates of cortical thickening over three years between long term users vs. short term or nonusers of bisphosphonates.
Difference in rates of subtrochanteric fractures over three years between long term users vs. short term or nonusers of bisphosphonates.
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Shane E, Burr D, Ebeling PR, Abrahamsen B, Adler RA, Brown TD, Cheung AM, Cosman F, Curtis JR, Dell R, Dempster D, Einhorn TA, Genant HK, Geusens P, Klaushofer K, Koval K, Lane JM, McKiernan F, McKinney R, Ng A, Nieves J, O'Keefe R, Papapoulos S, Sen HT, van der Meulen MC, Weinstein RS, Whyte M; American Society for Bone and Mineral Research. Atypical subtrochanteric and diaphyseal femoral fractures: report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res. 2010 Nov;25(11):2267-94. doi: 10.1002/jbmr.253.
Odvina CV, Zerwekh JE, Rao DS, Maalouf N, Gottschalk FA, Pak CY. Severely suppressed bone turnover: a potential complication of alendronate therapy. J Clin Endocrinol Metab. 2005 Mar;90(3):1294-301. doi: 10.1210/jc.2004-0952. Epub 2004 Dec 14.
Michael M Ward, M.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
120 participants (actual enrollment reported by the registry).
First Submitted
May 20, 2011
First Posted
May 25, 2011
Study Start
May 4, 2011
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Armamento-Villareal R, Napoli N, Panwar V, Novack D. Suppressed bone turnover during alendronate therapy for high-turnover osteoporosis. N Engl J Med. 2006 Nov 9;355(19):2048-50. doi: 10.1056/NEJMc062268. No abstract available.
Bhattacharyya T, Jha S, Wang H, Kastner DL, Remmers EF. Hypophosphatasia and the risk of atypical femur fractures: a case-control study. BMC Musculoskelet Disord. 2016 Aug 9;17:332. doi: 10.1186/s12891-016-1191-8.
Study Completion
January 11, 2017
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
July 2, 2017
Record last verified: 2017-01-11
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Source: ClinicalTrials.gov.
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