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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00383422
Registration number
NCT00383422
Ethics application status
Date submitted
29/09/2006
Date registered
3/10/2006
Date last updated
28/01/2010
Titles & IDs
Public title
Study Comparing Arzoxifene With Raloxifene in Women After Menopause With Osteoporosis
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Scientific title
The Comparison of the Efficacy and Safety of Arzoxifene Versus Raloxifene in Postmenopausal Women With Osteoporosis
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Secondary ID [1]
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H4Z-MC-GJAR
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Secondary ID [2]
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8580
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoporosis, Postmenopausal
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Condition category
Condition code
Musculoskeletal
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Osteoporosis
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Reproductive Health and Childbirth
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Menstruation and menopause
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Arzoxifene
Treatment: Drugs - Raloxifene
Experimental: 1 -
Active Comparator: 2 -
Treatment: Drugs: Arzoxifene
20 mg, oral, tablet, once a day for 52 weeks
Treatment: Drugs: Raloxifene
60 mg, oral, tablet, once a day for 52 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percent change in Lumbar Spine BMD
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Assessment method [1]
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Timepoint [1]
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baseline to 12 months
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Secondary outcome [1]
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Secondary BMD measures of total hip and femoral neck
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Assessment method [1]
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Timepoint [1]
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at 6 and 12 months
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Secondary outcome [2]
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Biochemical markers of bone metabolism assessed
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Assessment method [2]
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Timepoint [2]
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baseline, 3, 6, and 12 months
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Secondary outcome [3]
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Assessment of coagulation parameters
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Assessment method [3]
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Timepoint [3]
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baseline, 3, 6, and 12 months
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Secondary outcome [4]
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Breast Density by mammogram
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Assessment method [4]
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Timepoint [4]
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screening and 12 months
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Eligibility
Key inclusion criteria
- Must have osteoporosis
- Must be between 50 and 75 years old and be able to walk
- Have at least two of your back bones that can be x-rayed
- Have not had a period in at least two years
- Be willing to have blood tests
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Minimum age
50
Years
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Maximum age
75
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Have a bone disease other than osteoporosis
- History of estrogen dependent cancer
- History of stroke or certain heart problems
- Possibly have an allergy to raloxifene or arzoxifene
- Have certain abnormal lab values
- History of seizure disorder
- Have unexplained vaginal bleeding or an abnormal pap smear
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2008
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Sample size
Target
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Accrual to date
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Final
320
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Randwick
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Georgia
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Country [2]
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United States of America
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State/province [2]
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Iowa
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Country [3]
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United States of America
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State/province [3]
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Montana
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Country [4]
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United States of America
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State/province [4]
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Ohio
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Country [5]
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United States of America
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State/province [5]
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Texas
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Country [6]
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Argentina
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State/province [6]
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Buenos Aires
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Country [7]
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Canada
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State/province [7]
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British Columbia
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Country [8]
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Canada
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State/province [8]
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Nova Scotia
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Country [9]
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Canada
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State/province [9]
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Ontario
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Country [10]
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Canada
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State/province [10]
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Quebec
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Country [11]
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France
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State/province [11]
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Amiens
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Country [12]
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France
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State/province [12]
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Orleans
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Country [13]
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France
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State/province [13]
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Vandoeuvre Les Nancy
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Country [14]
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Italy
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State/province [14]
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Rome
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Country [15]
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Italy
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State/province [15]
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Torino
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Country [16]
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Spain
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State/province [16]
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Barcelona
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Country [17]
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Spain
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State/province [17]
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Madrid
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Country [18]
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Taiwan
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State/province [18]
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Changhua
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Country [19]
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Taiwan
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State/province [19]
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Taipei
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Country [20]
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Taiwan
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State/province [20]
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Tao-Yuan
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to compare the effect of arzoxifene to raloxifene on the bone
mineral density (bone strength).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00383422
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
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Address
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Eli Lilly and Company
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00383422
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