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ISRCTN
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ISRCTN85429598
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ClinicalTrials.gov identifier
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Public title
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Effect of simvastatin on bone markers in osteopenic women: a placebo-controlled, dose-ranging trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United States of America
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Disease/condition/study domain
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Osteopenia
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Participants - inclusion criteria
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1. Women with osteopenia
2. Not taking oestrogen
3. Selective oestrogen receptor modulators
4. Bisphosphonates
5. Calcitonin
6. 3-hydroxy-3-methylglutaryl coenzyme A (HMG-coA) reductase inhibitors
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/02/2001
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Anticipated end date
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01/05/2001
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Status of trial
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Completed
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Patient information material
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Target number of participants
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24
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Interventions
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1. Placebo once a day, at bedtime (qhs)
2. Simvastatin 20 mg qhs
3. Simvastatin 40 mg qhs
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Merck & Co. Inc. (USA) - unrestricted grant
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=11879528
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Contact name
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Dr
Judith
Hsia
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Address
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George Washington University
2150 Pennsylvania Ave NW
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City/town
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Washington DC
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Zip/Postcode
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20037
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Country
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United States of America
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Tel
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+1 202 004 5461
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Fax
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+1 202 994 3673
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Email
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domjah@gwumc.edu
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Sponsor
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George Washington University (USA)
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Address
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2150 Pennsylvania Ave NW
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City/town
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Washington DC
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Zip/Postcode
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20037
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Country
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United States of America
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Date applied
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26/02/2002
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Last edited
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06/09/2007
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Date ISRCTN assigned
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26/02/2002
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