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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
Scientific title
The Comparison of the Efficacy and Safety of Arzoxifene Versus Raloxifene in Postmenopausal Women With Osteoporosis
Secondary ID [1] 0 0
H4Z-MC-GJAR
Secondary ID [2] 0 0
8580
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis, Postmenopausal 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent change in Lumbar Spine BMD
Timepoint [1] 0 0
baseline to 12 months
Secondary outcome [1] 0 0
Secondary BMD measures of total hip and femoral neck
Timepoint [1] 0 0
at 6 and 12 months
Secondary outcome [2] 0 0
Biochemical markers of bone metabolism assessed
Timepoint [2] 0 0
baseline, 3, 6, and 12 months
Secondary outcome [3] 0 0
Assessment of coagulation parameters
Timepoint [3] 0 0
baseline, 3, 6, and 12 months
Secondary outcome [4] 0 0
Breast Density by mammogram
Timepoint [4] 0 0
screening and 12 months

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
Minimum age
50 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2008
Sample size
Target
Accrual to date
Final
320
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
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
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Iowa
Country [3] 0 0
United States of America
State/province [3] 0 0
Montana
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Argentina
State/province [6] 0 0
Buenos Aires
Country [7] 0 0
Canada
State/province [7] 0 0
British Columbia
Country [8] 0 0
Canada
State/province [8] 0 0
Nova Scotia
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec
Country [11] 0 0
France
State/province [11] 0 0
Amiens
Country [12] 0 0
France
State/province [12] 0 0
Orleans
Country [13] 0 0
France
State/province [13] 0 0
Vandoeuvre Les Nancy
Country [14] 0 0
Italy
State/province [14] 0 0
Rome
Country [15] 0 0
Italy
State/province [15] 0 0
Torino
Country [16] 0 0
Spain
State/province [16] 0 0
Barcelona
Country [17] 0 0
Spain
State/province [17] 0 0
Madrid
Country [18] 0 0
Taiwan
State/province [18] 0 0
Changhua
Country [19] 0 0
Taiwan
State/province [19] 0 0
Taipei
Country [20] 0 0
Taiwan
State/province [20] 0 0
Tao-Yuan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare the effect of arzoxifene to raloxifene on the bone
mineral density (bone strength).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00383422
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries