Back to resultsCarotid Artery Intima-Media Thickness Following Exposure to Raloxifene or Placebo
Primary Purpose
Osteoporosis, Post-Menopausal
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
raloxifene
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis, Post-Menopausal
Eligibility Criteria
Inclusion Criteria:
- Patients must have completed the Eli Lilly and Company clinical trial CORE (H3S-MC-GGJY) inclusive of visit 5, in one of the 9 participating study sites in California.
- Patients must have been dispensed study drug in the CORE trial (H3S-MC-GGJY).
Exclusion Criteria:
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
- Have previously withdrawn from this exploratory study or any other study investigating raloxifene
- Are employed by Eli Lilly and Company (that is, employees, temporary contract workers, or designees responsible for the conduct the study). Immediate family of Eli Lilly and Company employees may participate in Lilly-sponsored clinical trials, but are not permitted to participate at an Eli Lilly and Company facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
- Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
Sites / Locations
- 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.
- 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.
- 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.
- 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.
- 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.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
raloxifene
placebo
Outcomes
Primary Outcome Measures
Test the hypothesis that in postmenopausal women with osteoporosis who took lipid lowering meds for more than 6 months > 80% compliant with study drug during CORE trial, mean carotid IMT will be lower in patients treated with raloxifene than placebo
Secondary Outcome Measures
To test the hypothesis that, in postmenopausal women with osteoporosis, mean carotid IMT will be significantly lower in patients treated with raloxifene as compared to mean carotid IMT in patients treated with placebo in the following:
All enrolled patients who have not been exposed to lipid lowering medication for more than 6 months while in the CORE trial, regardless of study drug compliance.
All enrolled patients, regardless of lipid lowering drug exposure or compliance with study drug while in CORE
All enrolled patients who were at least 80% compliant with study drug while in CORE, regardless of use of lipid lowering therapy
Full Information
NCT ID
NCT00532246
First Posted
September 18, 2007
Last Updated
September 18, 2007
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00532246
Brief Title
Carotid Artery Intima-Media Thickness Following Exposure to Raloxifene or Placebo
Official Title
A Study of Carotid Artery Intima-Media Thickness Following Exposure to Raloxifene HCl or Placebo
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to measure carotid artery IMT at a single visit in a subset of women previously enrolled in the CORE (H3S-MC-GGJY) trial
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Post-Menopausal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
147 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
raloxifene
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
raloxifene
Other Intervention Name(s)
LY139481
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Test the hypothesis that in postmenopausal women with osteoporosis who took lipid lowering meds for more than 6 months > 80% compliant with study drug during CORE trial, mean carotid IMT will be lower in patients treated with raloxifene than placebo
Secondary Outcome Measure Information:
Title
To test the hypothesis that, in postmenopausal women with osteoporosis, mean carotid IMT will be significantly lower in patients treated with raloxifene as compared to mean carotid IMT in patients treated with placebo in the following:
Title
All enrolled patients who have not been exposed to lipid lowering medication for more than 6 months while in the CORE trial, regardless of study drug compliance.
Title
All enrolled patients, regardless of lipid lowering drug exposure or compliance with study drug while in CORE
Title
All enrolled patients who were at least 80% compliant with study drug while in CORE, regardless of use of lipid lowering therapy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have completed the Eli Lilly and Company clinical trial CORE (H3S-MC-GGJY) inclusive of visit 5, in one of the 9 participating study sites in California.
Patients must have been dispensed study drug in the CORE trial (H3S-MC-GGJY).
Exclusion Criteria:
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
Have previously withdrawn from this exploratory study or any other study investigating raloxifene
Are employed by Eli Lilly and Company (that is, employees, temporary contract workers, or designees responsible for the conduct the study). Immediate family of Eli Lilly and Company employees may participate in Lilly-sponsored clinical trials, but are not permitted to participate at an Eli Lilly and Company facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
La Jolla
State/Province
California
Country
United States
Facility Name
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.
City
Menlo Park
State/Province
California
Country
United States
Facility Name
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.
City
Oakland
State/Province
California
Country
United States
Facility Name
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.
City
San Diego
State/Province
California
Country
United States
Facility Name
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.
City
Walnut Creek
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Carotid Artery Intima-Media Thickness Following Exposure to Raloxifene or Placebo
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